Apparatus and methods for treatment of morbid obesity

ABSTRACT

Apparatus and methods are described for treatment of morbid obesity using minimally invasive techniques. The apparatus includes a system of components that may be used separately or in combination for effectively reducing stomach volume, bypassing a portion of the stomach and/or small intestines, reducing nutrient absorption in the stomach and/or small intestines and/or depositing minimally or undigested food farther than normal into the intestines, thereby stimulating intestinal responses. The components described include an artificial stoma device, a gastric sleeve device, an intestinal sleeve device, a combined gastrointestinal sleeve device and permanent and detachable attachment systems. Also described are devices for delivering and deploying the components of the system.

CROSS-REFERENCE TO OTHER APPLICATIONS

The present application claims the benefit under 35 U.S.C. §120 as acontinuation of U.S. patent application Ser. No. 14/738,597 filed onJun. 12, 2015, which is in turn a continuation of U.S. patentapplication Ser. No. 10/698,148, filed on Oct. 31, 2003, which in turnclaims the benefit under 35 U.S.C. §119(e) as a nonprovisional of U.S.Provisional Patent Applications 60/422,987, filed on Nov. 1, 2002, forApparatus and Methods for Treatment of Morbid Obesity; 60/430,857, filedon Dec. 3, 2002, for Biliopancreatic Diverter Tube for Treatment ofMorbid Obesity; 60/437,513, filed on Dec. 30, 2002, for Apparatus andMethods for Gastric Surgery, 60/448,817, filed on Feb. 21, 2003, forSurgical Fastener System and Method for Attachment within a HollowOrgan, and 60/480,485, filed on Jun. 21, 2003 for GastrointestinalSleeve Device and Method of Use; and 60/428,483, filed on Nov. 22, 2002,for Gastroplasty Clamp. These aforementioned applications as well as allother patents and patent applications referred to herein are herebyincorporated by reference in their entireties.

BACKGROUND OF THE INVENTION

Bariatrics is the field of medicine encompassing the study ofoverweight, its causes, prevention and treatment. Bariatric surgery is atreatment for morbid obesity that involves alteration of a patient'sdigestive tract to encourage weight loss and to help maintain normalweight. Known bariatric surgery procedures include jejuno-ileal bypass,jejuno-colic shunt, biliopancreatic diversion, gastric bypass, Roux-en-Ygastric bypass, gastroplasty, gastric banding, vertical bandedgastroplasty, and silastic ring gastroplasty. A more complete history ofbariatric surgery can be found in U.S. Provisional Patent Application60/422,987 Apparatus and Methods for Treatment of Morbid Obesity andalso on the website of the American Society for Bariatric Surgery athttp://www.asbs.org.

Medical sleeve devices for placement in a patient's stomach aredescribed by Rockey in U.S. Pat. Nos. 4,501,264, 4,641,653 and4,763,653. The medical sleeve described in these patents are said toreduce the surface area available for absorption in the stomach, howeverit is not configured to effectively reduce the volume of the stomach norwill the device described isolate ingested food from stomach secretions.The medical sleeve is not configured to be deployed in a patient's smallintestine.

Other sleeve devices for placement in a patient's intestines aredescribed in U.S. Pat. No. 4,134,405 (Smit), U.S. Pat. No. 4,315,509(Smit), U.S. Pat. No. 5,306,300 (Berry), and U.S. Pat. No. 5,820,584(Crabb). The sleeve devices described in these patents are said to beplaced at the lower end of the stomach and therefore do not serve toisolate ingested food from the digestive secretions of the stomach.These sleeve devices are not configured to be deployed in a patient'sstomach or to effectively reduce the volume of the patient's stomach orsmall intestine.

In U.S. Patent Application US 2003/0040804, Stack et al. describe asatiation device to aid in weight loss by controlling feelings ofhunger. The patent application describes an antral tube that expandsinto the antrum of the stomach to create a feeling of satiation. Thedevices described are not configured to isolate ingested food andliquids from digestive secretions in the stomach or the intestines.

In U.S. Patent Application US 2003/0040808, Stack et al. describe asatiation device for inducing weight loss in a patient includes atubular prosthesis positionable at the gastro-esophageal junctionregion, preferably below the z-line. The prosthesis is placed such thatan opening at its proximal end receives masticated food from theesophagus, and such that the masticated food passes through the pouchand into the stomach via an opening in its distal end.

In U.S. Patent Application US 2003/0093117, Sadaat describes animplantable artificial partition that includes a plurality of anchorsadapted for intraluminal penetration into a wall of thegastro-intestinal lumen to prevent migration or dislodgement of theapparatus, and a partition, which may include a drawstring or a toroidalballoon, coupled to the plurality of anchors to provide a localreduction in the cross-sectional area of the gastro-intestinal lumen.

In U.S. Patent Application US 2003/0120265, Deem et al. describe variousobesity treatment tools and methods for reducing the size of the stomachpouch to limit the caloric intake as well as to provide an earlierfeeling of satiety. The smaller pouches may be made using individualanchoring devices, rotating probes, or volume reduction devices applieddirectly from the interior of the stomach. A pyloroplasty procedure torender the pyloric sphincter incompetent and a gastric bypass procedureusing atraumatic magnetic anastomosis devices are also described.

In U.S. Patent Application US 2003/0144708, Starkebaum describes methodsand systems for treating patients suffering from eating disorders andobesity using electrical stimulation directly or indirectly to thepylorus of a patient to substantially close the pylorus lumen to inhibitemptying of the stomach.

The present invention also relates to apparatus and methods forperforming gastric and esophageal surgery that can be applied usingminimally invasive techniques for creating a stoma or restriction in apatient's stomach or esophagus. The apparatus and methods are useful fortreatment of morbid obesity and for treatment of gastroesophageal refluxdisease (GERD). Surgical treatments for gastroesophageal reflux diseaseinclude fundoplasty and fundoplication, which can be performed usingopen surgical techniques or laparoscopic surgical techniques. Theseprocedures create a valve-like structure at the gastroesophagealjunction to prevent reflux of the stomach contents. Although methodshave been proposed for performing fundoplication using peroralendoscopic techniques, these methods have not been widely adopted.Examples of instruments and methods for performing fundoplication can befound in the following patents: WO0185034 Devices and related methodsfor securing a tissue fold, U.S. Pat. No. 6,312,437 Flexible endoscopicsurgical instrument for invagination and fundoplication.

FIELD OF THE INVENTION

The present invention relates generally to apparatus and methods fortreatment of obesity, and particularly morbid obesity. In particular, itrelates to apparatus and methods that can be applied using minimallyinvasive techniques for effectively reducing stomach volume, bypassing aportion of the stomach and/or small intestines and/or reducing nutrientabsorption in the stomach and/or small intestines

SUMMARY OF THE INVENTION

In keeping with the foregoing discussion, the present invention providesapparatus and methods that can be applied using minimally invasivetechniques for treatment of obesity, and particularly morbid obesity.The apparatus takes the form of a system of components that may be usedseparately or in combination for effectively reducing stomach volume,bypassing a portion of the stomach and/or small intestines, reducingnutrient absorption in the stomach and/or small intestines and/ordepositing minimally or undigested food farther than normal into theintestines (thereby stimulating intestinal responses).

In one aspect of the invention, the system may include an artificialstoma device located in the stomach or lower esophagus that can reducethe flow of food into the stomach (when located in the stomach) or backfrom the stomach into the esophagus (when located in the esophagus or atthe gastroesophageal junction). Alternatively, the system may utilize asurgically created artificial stoma. Stomas that prevent flow of gastriccontents into the esophagus can be used in the treatment of GERD. Thestoma is introduced transesophageally and implanted under visualizationwith a flexible endoscope. The stoma may be anchored to the esophagealor stomach wall using sutures, staples or clips. Alternatively, thestoma may be anchored with a sutureless attachment that does notpenetrate the esophageal or stomach wall. Optionally, multiple stomascan be installed, e.g. one for GERD and one for restriction of foodpassage. Optionally, the stoma may be used in conjunction with gastricsuturing, stapling or banding to create a narrow passage forinstallation of the stoma and/or for reduction of gastric volume. Thegastric stapling or banding may be applied using transesophageal orlaparoscopic techniques. Optionally the stoma may be in multiple partswhere the parts may be individually placed, replaced or exchanged.Optionally, the stoma may have an adjustable opening to vary the flow offood through the stoma and/or allow the passage of diagnostic ortherapeutic devices such as endoscopes. The adjustable stoma may beadjusted at the time of implantation or it may be adjustable remotelyafter implantation without invasive procedures. Alternatively, the stomamay be a self-adjusting “smart stoma” that opens and/or closes inresponse to stomach conditions.

In another aspect, the system may include an internal gastric sleevethat may be used separately or used with, attached to or integrated withthe artificial stoma component. The gastric sleeve may have afunnel-shaped entry with a reinforced anchoring segment or otheranchoring mechanism for attachment in the stomach at or near thegastroesophageal junction. Optionally, the artificial stoma componentmay be positioned a clinically significant distance distal to the sleeveattachment. When placed in the stomach, the entry portion of the sleeveproximate to the stoma effectively reduces the volume of the stomachbecause the flow of solid food is limited to the lumen of the sleeve.When combined with a restrictive stoma, the sleeve functions as thepouch in a gastric bypass or vertical banded (or other) gastroplasty.The sleeve can be designed and placed to maximize the amount of stomachwall included by the sleeve opening and therefore included in the pouchthereby formed. This will enable a maximum number of stretch receptorsand other stimulating mechanisms in the stomach to transmit satiety(fullness) signals to help reduce food intake.

The entire gastric sleeve or a portion of it can be porous orsemipermeable to allow the flow of digestive secretions into the sleeveand to allow the flow of nutrients and/or fluids out through the wall ofthe gastric sleeve. Valves may be provided in the wall of the gastricsleeve to allow digestive secretions to enter the sleeve, but to preventsolid food and/or nutrients from flowing out through the wall of thesleeve. Alternatively, the entire gastric sleeve or a portion of it canbe nonporous or impermeable to act as an internal gastric bypass. Incertain embodiments, the wall of the gastric sleeve is flexible to allowthe peristaltic motions of the stomach to effect movement of foodthrough the gastric sleeve. The wall of the sleeve may be reinforcedwith rings or a spiral made of wire and/or plastic. Alternatively, thegastric sleeve may be attached to an artificial stoma component thatincludes its own anchoring mechanism. Optionally, the distal end of thegastric sleeve may be anchored in the region of the pylorus. Optionallythe distal end of the gastric sleeve can incorporate an enlargedreservoir portion proximal to the pylorus. Optionally the sleeve caninclude coatings on its interior and/or exterior to enhance the surfaceproperties of the sleeve in clinically relevant manners.

In conjunction with the stoma and/or gastric sleeve, the volume of thestomach can be reduced by suturing, stapling using open, transesophagealor laparoscopic techniques. Alternatively or in addition, a gastricballoon or other volume displacement device may be used in conjunctionwith the gastric sleeve to provide a feeling of satiety. Theseadjunctive techniques have the effect of further reducing nutrientintake (in the case of a stomach reduction and pouch formation upstreamof a stoma) and enhancing the effect of peristaltic motions of thestomach for moving food through the gastric sleeve intake (in the caseof a stomach reduction downstream of a stoma where there is a gastricsleeve). A gastric sleeve that extends beyond the pylorus, with orwithout an intestinal sleeve, can allow use of the pylorus as a naturalstoma by configuring the sleeve to close by the pylorus and then open toallow passage of food when the muscles of the pylorus relax.

One advantage of using an internal gastric sleeve over prior art gastricvolume reduction techniques is that volume reduction can be betterdefined in that the patient cannot deliberately or inadvertentlyincrease the volume of the sleeve over time by overeating as occurs whenthe stomach wall stretches. Another advantage of an internal sleeve overprior art banding techniques is that stomach wall is not trapped betweenan external structure and ingested food whereby the stomach wall issubject to compression due to overeating.

In another aspect, the system may include an internal intestinal sleevethat may be used separately or used with, attached to or integrated withthe internal gastric sleeve and/or artificial stoma component. Theentire intestinal sleeve or a portion of it can be porous orsemipermeable to allow the flow of digestive secretions into the sleeveand to allow the flow of nutrients and/or fluids out through the wall ofthe sleeve. Valves may be provided in the wall of the intestinal sleeveto allow digestive secretions to enter the sleeve, but to prevent solidfood and/or nutrients from flowing out through the wall of the sleeve.Alternatively, the entire intestinal sleeve or a portion of it can benonporous or impermeable to act as an internal intestinal bypass. Incertain embodiments, the wall of the intestinal sleeve is flexible toallow the peristaltic motions of the intestinal wall to effect movementof food through the intestinal sleeve. The wall of the sleeve may bereinforced with rings or a spiral made of wire and/or plastic.Optionally these components can include radiopaque materials forvisualization of the device when it is in the body. Optionally thesleeve can include coatings on its interior and/or exterior to enhancethe surface properties of the sleeve in clinically relevant manners.

In one aspect of the present invention, there is provided a method oftreating a patient. The method includes the steps of providing agastrointestinal sleeve having a proximal end, a distal end and a lengthof at least about 50 cm. The sleeve is positioned with the proximal endadjacent an attachment site in the vicinity of the lower esophagealsphincter, with the distal end extending transluminally at least as faras the jejunum. At least one plication is formed at the attachment site,and the sleeve is attached to the plication. Two or three or four offive or more plications may alternatively be formed, for direct orindirect attachment to the sleeve. The distal end of the sleeve mayextend into the intestine at least as far as the ligament of Treitz. Theproviding step may comprise providing a sleeve having a substantiallyconstant diameter throughout its length.

Optionally, the intestinal sleeve may have a proximal end with areinforced anchoring segment or other anchoring mechanism for attachmentin the region of the pylorus. Alternatively, the intestinal sleeve maybe attached to or continuous with the internal gastric sleeve.Optionally, the distal end of the intestinal sleeve may include ananchoring mechanism.

Optionally, the above system components can include means of separatelyinstalling, replacing and/or removing single components. This wouldinclude means of reversibly attaching and connecting components. Thiswould allow a therapeutic device to be assembled over multipleoperations or in a single procedure. Alternatively, the above componentscan be preassembled with a specific combination of desired features foran individual patient and thereby installed and removed in a singleoperation. Preferably, each component of the system includes one or moreradiopaque and/or sonoreflective markers for enhanced imaging by X-ray,fluoroscopy and/or ultrasonic imaging.

Certain implementations of the invention will achieve some or all of thefollowing advantages:

1. Minimally invasive, peroral/transesophageal implantation, withoptional surgical and/or laparoscopic assist

2. Customizable to each patient and revisable in-situ based upon theresults of the intervention

3. Completely reversible using minimally invasive techniques

4. Lower morbidity, mortality

5. When used with a gastric and/or intestinal sleeve, does not allow anappreciable amount of digestion to occur until the food exits the sleeveinto the intestine by keeping food separate from gastric and/orintestinal secretions. This delivers undigested food to the jejunumwhere a dumping syndrome reaction and/or other results ofoverstimulation of the intestine may occur depending upon the clinicalsituation and the food ingested.

The system optionally includes a biliopancreatic diverter tube foreffectively reducing nutrient absorption in the small intestines bydiverting the release of digestive salts and enzymes from thegallbladder and pancreas into the small intestine downstream in thegastrointestinal tract, resulting in a reduction in the location and theamount of intestine exposed to digestible nutrients, and thus reducingthe digestion and absorption of fat and other sources of calories.

The system optionally includes a surgical fastener system for removablyor reversibly attaching a surgical appliance within a hollow organ in apatient's body. The surgical fastener system can be configured for manydifferent surgical applications within a patient's body. In manyapplications, it is desirable to removably or reversibly attach asurgical appliance within a hollow organ such that it can be removed orrevised at a later date. Examples of applications where the surgicalfastener system of the present invention can be used include: attachmentof an artificial stoma device or gastrointestinal sleeve device within apatient's stomach or intestines for treatment of morbid obesity,attachment of a valve or restriction in a patient's esophagus fortreatment of gastroesophageal reflux disease, attachment of a filterdevice within a patient's vena cava for treatment of thromboembolicdisease, and attachment of a valve or other device within a patient'saorta or urethra.

With these broader applications in mind, the surgical fastener systemwill be described in relation to a particular application for reversiblyattaching a surgical appliance within a patient's stomach or esophagusfor treatment of conditions including morbid obesity andgastroesophageal reflux disease. Morbid obesity can be surgicallytreated by creating a restriction in a patient's stomach to limit theamount of food that can enter the stomach. Alternatively or in addition,the patient's stomach and/or intestines can be partially bypassed, forexample using an internal gastrointestinal sleeve device, to reduce theamount of nutrients that are absorbed from the food as it passes throughthe gastrointestinal system. GERD can be treated by attachment of avalve or restriction in a patient's esophagus at the gastroseophagealjunction to prevent food and digestive juices from refluxing into theesophagus.

Certain embodiments of the fastener system utilize folding or plicationof the stomach and/or esophageal wall or other hollow organ to create areinforced attachment point for the fasteners. Various devices andmethods have been previously described utilizing fundoplication tocreate a restriction or a valve-like structure at the gastroesophagealjunction for treatment of gastroesophageal reflux disease. For example,see patents: U.S. Ser. No. 05/897,562, U.S. Ser. No. 06/312,437,US20020035370A1, WO00185034, WO00228289 and WO09922649, which are herebyincorporated by reference. By contrast, in certain embodiments of thepresent invention, the fastener system preferably attaches to thestomach or other hollow organ with a minimum of stress and deformation.One way of accomplishing this is by utilizing a multiplicity ofindependent fasteners attached around the inner periphery of the organwithout causing any narrowing or restriction in the organ.Alternatively, the fastener system may utilize a continuous ringstructure that is sized to fit closely with the inner diameter of theorgan without significant deformation of the organ. In the alternative,when a stoma or restriction is desired at the point of attachmentsystem, the fastener system and methods of the present invention can bemodified to create a narrowing, restriction or a valve-like structure inthe hollow organ simultaneously with providing a removable attachmentfor a surgical appliance or the like.

Alternatively or in addition, the system may optionally include asurgical instrument for creating a stoma or restriction in a patient'sstomach or esophagus using minimally invasive surgical techniques. Thisapparatus can also be used to create a plication or fold in the stomachor esophagus and furthermore can then be used to attach other devices tothe fold thereby created. In addition, the system may optionally includea stomal ring clip device implantable within the patient's stomach forforming and maintaining the stoma or restriction. The surgicalinstruments and the implantable stomal ring clip devices may be usedseparately or in combination depending on the needs of the individualpatient. Methods are described using the surgical instruments and theimplantable stomal ring clip devices separately and in combination forcreating a stoma or restriction in a patient's stomach or esophagus. Theapparatus and methods are useful for treatment of morbid obesity and canbe combined with other surgical techniques or devices as part of acomplete treatment regimen. The apparatus and methods are useful fortreatment of GERD by creating a restriction or a valve-like structure atthe gastroesophageal junction to prevent reflux of the stomach contents.

T-tag fasteners can be used to facilitate endoscopic attachment of thevarious components of the system to the tissues in or around thepatient's gastrointestinal tract. In addition, T-pledgets can be used insituations where reinforcement of the tissue to be attached is desired.For example, such fasteners can be used for fastening a stoma device, asleeve device or an attachment ring to the gastric wall. Optionally, thegastric wall may be folded into a single or double plication forattachment of the system components with the fasteners. Alternatively orin addition, where it is appropriate, laparoscopic assistance may beused for forming the plications or applying the fasteners. ExpandableT-tags and T-pledgets and other structures to reduce tissue erosion arealso described.

Apparatus and methods are described for performing an endoscopicgastropexy attachment procedure for anchoring the gastric wall to thepatient's diaphragm to provide greater support for the components of thesystem. A component of the system, such as a stoma device, a sleevedevice or an attachment ring, can be attached simultaneously or in asubsequent step with the gastropexy attachment. T-tag fasteners or thelike can be used to facilitate gastropexy attachment procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an artificial stoma device implanted within a patient'sstomach with a line of gastroplasty sutures or staples to create anarrow passage.

FIGS. 2A-2B shows a stoma device with a separate anchoring device in theform of an anchoring ring.

FIG. 3 shows an enlarged view of an artificial stoma device with avariable diameter stoma aperture.

FIGS. 4A-4B shows an alternate embodiment of an artificial stoma devicewith a variable diameter stoma aperture.

FIGS. 5A-5B show an adjustable stoma with an inflatable bladder, pumpand reservoir and with optional suture anchors.

FIGS. 6A-6D show wire fasteners useful for attaching the stoma deviceand forming a gastroplasty pouch.

FIGS. 7A-7B show an enlarged view of a smart stoma device with a stomaaperture that varies its diameter in response to conditions in thepatient's stomach.

FIG. 8A-8B show another embodiment of a smart stoma device with a stomaaperture that varies its diameter in response to conditions in thepatient's stomach.

FIGS. 9A-9B show an enlarged view of a smart stoma device with a closedloop controlled variable diameter stoma aperture.

FIGS. 10A-10C show an artificial stoma device with a suturelessanchoring mechanism.

FIG. 11 shows a gastric sleeve device with an artificial stoma deviceand a pyloric sleeve anchor implanted within a patient's stomach with aline of gastroplasty sutures or staples parallel to the sleeve.

FIGS. 12A-12E are detail drawings showing additional features of agastric or intestinal sleeve device.

FIG. 13 shows a detail drawing of a gastric or intestinal sleeve devicewith reinforcement rings.

FIG. 14 shows a detail drawing of a gastric or intestinal sleeve devicewith a spiral reinforcement.

FIG. 15 shows a combined gastric and intestinal sleeve device with anartificial stoma device implanted within a patient's stomach with a lineof gastroplasty sutures or staples parallel to the sleeve.

FIG. 16 shows a combined gastric and intestinal sleeve device with anartificial stoma device located within a funnel-shaped entry with areinforced suture area.

FIG. 17 shows an artificial stoma device implanted within a patient'sstomach with a line of gastroplasty sutures or staples to reduce thegastric volume. Also shown is a line of sutures or stapleslongitudinally dividing the small intestine to create a biliopancreaticchannel separate from the intestinal lumen.

FIG. 18 shows a cross section of the patient's small intestine showingthe biliopancreatic channel.

FIG. 19 shows an artificial stoma device implanted within a patient'sstomach with a line of gastroplasty sutures or staples to reduce thegastric volume and a line of sutures or staples longitudinally dividingthe small intestine to create a biliopancreatic channel with an optionalstent.

FIG. 20 shows a cross section of the patient's small intestine showingthe biliopancreatic channel with an optional stent.

FIG. 21 shows a combined gastric and intestinal sleeve device implantedwithin a patient's stomach with a gastric balloon to reduce the gastricvolume.

FIG. 22 illustrates an example of a gastrointestinal sleeve devicedeployed within a patient's gastrointestinal tract for treating morbidobesity.

FIGS. 23A and 23B illustrate a gastrointestinal sleeve device with ahealable, removable fixation system.

FIGS. 24A-24D illustrate various gastrointestinal sleeve devicesattached within a patient's stomach.

FIG. 25 illustrates a gastrointestinal sleeve device with a coaxialinflatable balloon surrounding the sleeve within the patient's stomach.

FIGS. 26A, 26B and 26C show a cross section of the gastrointestinalsleeve device with optional features intended to keep the lumen of thesleeve open even if the sleeve collapses.

FIGS. 27A and 27B show a cross section of the gastrointestinal sleevedevice with optional internal channels intended to keep the lumen of thesleeve open even if the sleeve collapses.

FIG. 28 illustrates an optional one-way valve feature of thegastrointestinal sleeve device.

FIG. 29 illustrates another example of a gastrointestinal sleeve devicedeployed within a patient's gastrointestinal tract for treating morbidobesity.

FIG. 30 illustrates another example of a gastrointestinal sleeve devicehaving a reservoir located above the patient's pyloric sphincter.

FIG. 31 illustrates another example of a gastrointestinal sleeve devicehaving an inflatable gastric balloon.

FIGS. 32A-32D illustrate optional features to assist in the deploymentof the gastrointestinal sleeve device within a patient'sgastrointestinal tract.

FIG. 33 shows a cutaway view of a portion of a human digestive system,with an embodiment of a biliopancreatic diverter tube in situ.

FIG. 34 shows an alternative embodiment of the biliopancreatic divertertube in situ.

FIG. 35 shows a method of delivering an embodiment of thebiliopancreatic diverter tube.

FIG. 36 illustrates several fastener segments, each segment havinggripping fingers for attachment of a surgical appliance within a holloworgan in a patient's body.

FIG. 37 illustrates a gastrointestinal sleeve device installed within apatient's stomach using the fasteners of FIG. 36.

FIG. 38 shows an alternative fastener system comprising an annularshaped member having gripping fingers for attachment of a surgicalappliance within a hollow organ in a patient's body.

FIG. 39 shows the device of FIG. 38 with a surgical appliance attached.

FIG. 40A shows an alternative fastener system comprising an annularshaped member wherein the surface of the annular shaped memberalternates between having tissue growth promoting materials, andnon-tissue growth promoting materials.

FIG. 40B shows a fastener system comprising fastener segments connectedwith a bioresorbable material to ease installation.

FIG. 41A shows an alternative fastener system comprising an annularshaped member wherein the surface of the annular shaped memberalternates between having tissue growth promoting materials, andnon-tissue growth promoting materials.

FIG. 41B shows an alternative fastener system comprising an comprisingan annular shaped member wherein the surface of the annular shapedmember alternates between having tissue growth promoting materials, andnon-tissue growth promoting materials.

FIG. 42A shows an alternative fastener system comprising an annularshaped member wherein the surface of the annular shaped memberalternates between having tissue growth promoting materials, andnon-tissue growth promoting materials.

FIG. 42B shows an alternative fastener system comprising an annularmember of rough segments having hooks coupled to smooth segments thatare made of a bioresorbable material.

FIGS. 43-45 show various embodiments of a fastener system that alsofunctions to create a stoma within a passageway that is more narrow thanthe original passageway.

FIG. 46A shows an alternative embodiment of a fastener system. FIG. 46Bshows the device of FIG. 46A being driven through a single tissue layer,with the attachment means positioned within the passageway and the coneshaped spring positioned on the opposite side.

FIG. 47A shows a clip that can be used to plicate tissue, and alsoprovide a platform for attaching another device or hanger. The clip isshown being used with one embodiment for a plication tool.

FIGS. 47B-47D show the sequence of steps used to deliver the clip ofFIG. 47A. This process may be repeated to collectively form a supportstructure for another device.

FIG. 47E shows another device that is positioned to hang from severalclips positioned within a passageway.

FIG. 47F shows an alternative clip embodiment having two separateattachment platforms.

FIG. 48 shows another embodiment of a fastener system comprising ahanger that also functions to hold two layers of folded tissue together.This fastener has a toggle that pivots on a hinge so that is can bealigned with the post as it is passed through tissue layers, and canthen be pivoted to hold the tissue layers together.

FIGS. 49-51 illustrate a surgical instrument for fastening tissue.

FIG. 52 shows a cross section of one possible configuration of thesurgical instrument shown in FIGS. 49-51.

FIG. 53 shows a surgical instrument comprised of a fastener deliverymechanism, and an anvil hingedly attached to an extension arm, used forcreation of a stoma or restriction in a patient's stomach that is sizedfor passage through an endoscope.

FIG. 54 shows a stoma created using fasteners.

FIGS. 55-57 show the sequence of steps for inserting a fastener ingreater detail.

FIG. 58 shows an example of a stomal ring clip device with only an upperring implanted in a patient's stomach, held in place with fasteners.

FIGS. 59-64 show a sequence of steps for using a surgical instrument toimplant a device similar to the device of FIG. 58.

FIG. 65 is an exploded view of a stomal ring clip device having upperand lower rings for forming a stoma or restriction in a patient'sstomach.

FIG. 66 shows an assembled view of the stomal ring clip device implantedin a patient's stomach.

FIG. 67 shows an example of a stomal ring clip device with an upper ringand a lower ring implanted in a patient's stomach.

FIG. 68 is an exploded view of an embodiment of a stoma ring clip with adependent gastrointestinal sleeve device.

FIG. 69 shows the device of FIG. 68 in situ.

FIG. 70 shows an embodiment of gastrointestinal sleeve device.

FIG. 71 shows the device of FIG. 70 in situ.

FIG. 72 illustrates another embodiment of a surgical instrument forfastening tissue.

FIG. 73 is an exploded view of a surgical fastener for use with thesurgical instrument of FIG. 72.

FIG. 74 shows the surgical fastener of FIG. 73 in a deployed condition.

FIGS. 75A-75F show a sequence of steps for deploying the surgicalfastener of FIG. 73.

FIG. 76 shows the surgical fastener of FIG. 73 being removed.

FIG. 77 shows a top view of an attachment ring device for attaching agastrointestinal sleeve device within a patient's stomach.

FIG. 78 shows a cross section of the attachment ring device of FIG. 77.

FIG. 79 shows a cross section of the attachment ring device of FIG. 77with a gastrointestinal sleeve device installed.

FIG. 80 shows a cross section of the attachment ring device and thegastrointestinal sleeve device of FIG. 79 with an optional leak shieldinstalled.

FIG. 81 shows a top view of another embodiment of an attachment ringdevice for attaching a gastrointestinal sleeve device within a patient'sstomach.

FIG. 82 shows a cross section of the attachment ring device of FIG. 81.

FIG. 83 shows a cross section of the attachment ring device of FIG. 81with a gastrointestinal sleeve device installed.

FIGS. 84A-84C show a gastrointestinal sleeve device with an integralleak shield.

FIG. 85 illustrates the components of a kit for delivering and deployinga gastrointestinal sleeve device.

FIGS. 86A-86C illustrate three options for preloading a gastrointestinalsleeve device for delivery and deployment.

FIGS. 87A-87D illustrate four options for sealing the distal end of agastrointestinal sleeve device during delivery and deployment.

FIGS. 88A-88B illustrate a method of delivering and deploying agastrointestinal sleeve device.

FIGS. 89A-89D illustrate an alternate rivet design.

FIG. 90A illustrates a method of laparoscopically assisted formation ofa double plication.

FIG. 90B illustrates a device for laparoscopically assisted formation ofa double plication.

FIGS. 91A and 91B illustrate T-tag and T-pledget ring attachment.

FIG. 92 illustrates a gastropexy apparatus.

FIGS. 93A-93D illustrate examples of expanding T-tag fasteners.

FIGS. 94A-94C illustrate placement of T-tag fasteners.

FIG. 95 illustrates extragastric laparoscopic attachment of anintragastric ring.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The present invention provides apparatus and methods for treatment ofobesity, and particularly morbid obesity. The apparatus takes the formof a system of components that may be used separately or in combinationfor effectively reducing stomach volume, bypassing a portion of thestomach and/or small intestines and reducing nutrient absorption in thestomach and/or small intestines. Each of the components can be implantedusing minimally invasive techniques, preferably using a transesophagealapproach under visualization with a flexible endoscope. Optionally,laparoscopic surgical techniques may be used to assist in theimplantation of the components and/or for adjunctive therapies in thedigestive tract.

In the following, the word endoscope (and endoscopic) will refer to aninstrument for visually examining the interior of a bodily canal or ahollow organ. For procedures performed via a peroral route, a flexibleendoscope, such as a gastroscope, is generally preferred. The wordlaparoscope (laparoscopic) will refer to rigid endoscopes generallypassed through surgically created portals. Also in the following theterms biodegradable and bioresorbable will be used interchangeably. Alsoin the following the term stoma will be used to refer to an openingformed in a hollow organ which may or may not be configured to restrictflow of food and/or digestive juices. Endoscopic overtube and orogastrictube sleeve are also used interchangeably.

In one aspect of the invention, the system may include an artificialstoma 100 located in the stomach or lower esophagus that can optionallyreduce the flow of food into the stomach. FIG. 1 shows an artificialstoma device 100 implanted within a patient's stomach. The stoma device100 is introduced transesophageally and implanted under visualizationwith a flexible endoscope. The stoma may be optionally restrictive ornon-restrictive of food flow. The stoma may be anchored to theesophageal or stomach wall using sutures, staples, clips or otheranchoring mechanisms as described herein. Optionally, the stoma 100 maybe used in conjunction with gastric suturing, stapling or banding tocreate a narrow passage for installation of the stoma and/or forreduction of gastric volume. The gastric suturing, stapling or bandingmay be applied using open, transesophageal or laparoscopic techniques.In the example shown in FIG. 1, a line of gastroplasty sutures orstaples 104 has been used to create a small gastroplasty pouch with anarrow passage for installation of the stoma 100. The gastroplastysutures or staples 104 may be applied using open, transesophageal orlaparoscopic techniques.

The artificial stoma 100 may include a fabric cuff on the outercircumference to facilitate ingrowth of tissue to secure the stomadevice 100 in place. In-growth can be further facilitated by partialtransection of the gastric wall through the mucosa. This will put thefabric cuff in contact with muscularis. Alternatively or in addition, anumber of suture attachment points can be included on the outercircumference of the stoma device. The suture attachment points may takethe form of suture attachment loops attached to the outer circumferenceof the stoma device or a ring with suture attachment holes formed in it.

In certain embodiments, the outer circumference of the stoma 100 isflexible and elastic with properties to minimize the resistance of thestoma 100 to motion of the stomach at the stomal attachment points. Thisalso serves to minimize the forces that can lead to tissue erosion.

In an alternative embodiment, the artificial stoma device may include aseparate anchoring device that may be in the form of an anchoring ringor a series of anchoring points for attachment to the gastric oresophageal wall. FIGS. 2A-2B shows a stoma device 100 with a separateanchoring device in the form of an anchoring ring 108. The anchoringring 108 may include a sutureless anchoring mechanism and/or a fabriccuff or other attachment points for sutures, staples, clips or otheranchoring mechanisms. The anchoring device 108 is initially implanted inthe stomach or lower esophagus, as shown in FIG. 2A. Preferably, thetissue is allowed to heal for a number of weeks before the artificialstoma 100 is installed by attaching it to the anchoring device 108 in asubsequent procedure, as shown in FIG. 2B.

Optionally, the stoma 100 may have an adjustable opening 110 to vary theflow of food through the stoma. FIG. 3 shows an enlarged view of anartificial stoma device 100 a variable diameter stoma aperture 110. Theadjustable stoma 100 may be adjusted at the time of implantation and/orit may be adjustable remotely after implantation without invasiveprocedures.

The adjustable stoma 100 may be formed as a cylinder that can becollapsed for insertion, and then expanded when in place. Preferably,the outer diameter will maintain a set, but somewhat elastic, diameterto facilitate fixation in the body. The outer circumference may besupported by a metal lattice 114 that is deformed permanently by theinitial deployment. Possible materials for the metal lattice 114 include304 and 316 stainless steel. Deployment can be by a coaxial ballooncatheter.

In certain embodiments, the inner circumference of the adjustable stomais supported by a metal lattice 116 made of a NiTi alloy where thedeformation needed to deploy the device and set the size of the innerdiameter can be reversed by the application of heat. Heat could beapplied by a balloon catheter with circulating heated fluid, RF energyor other known means. The NiTi lattice 116 can then be expanded anddeformed to the desired diameter by a balloon catheter inflated in thestoma aperture 110. Alternatively, the lattice 116 may be made of amaterial that is plastically deformable, such as stainless steel, toadjust the stoma aperture 110 larger using a dilator, such as aninflatable balloon.

In the example of FIG. 3, the entire adjustable stoma 100 is covered bya biocompatible material 118, such as an elastomer, to prevent ingressof fluids into the interior of the adjustable stoma 100. Examples ofsuitable materials include silicone (e.g. Dow Silastic or similarmaterial from Nusil Technology) and polyurethane (e.g. Dow Pellethane).The stoma could alternately be constructed from or coated with afluoropolymer such as a PFA, FEP or PTFE (e.g. Dupont Teflon). The outercircumference is adapted for accepting sutures or staples for attachmentwithin the body.

FIGS. 4A-4B shows an alternate embodiment of an artificial stoma device100 with a variable diameter stoma aperture 110. The inner circumferenceof the adjustable stoma is supported by a wire coil 126 that helps tomaintain the adjustable stoma aperture 110. In certain embodiments, thewire coil 126 is made of a shape-memory NiTi alloy, so that the stomaaperture 110 can be adjusted larger or smaller using the methoddescribed below. Alternatively, the wire coil 126 may be made of amaterial that is plastically deformable, such as stainless steel, toadjust the stoma aperture 110 larger using a dilator, such as aninflatable balloon. Alternatively or in addition, a lattice or othereasily deformable structure may be used in place of the wire coil 126.The wire coil 126 may be Stomas of this type are preferably inserted ina collapsed state to facilitate passage through the esophagus. This typeof stoma and other collapsible stomas can utilize a removable sleeve orother means for temporarily holding the stoma in the collapsed state.

Any of the restrictive stoma devices described herein can be placed inthe lower esophagus or near the GEJ to prevent reflux. Esophageal oranti-relux stomas will preferably be configured to allow one-way flowand seal against or resist retrograde flow. This could be accomplishedwith a smart type stoma as described herein, preferably one that closesin response to gastric secretions, or a one-way valve, such as aduckbill or flap type valve.

In one embodiment, the stoma device 100 may be implanted and adjustedaccording to the following method:

Stoma Placement

1) place oral-gastric tube into the patient's stomach, the oral-gastrictube can optionally include a separable sleeve;

2) insert a guidewire through the oral-gastric tube into the stomach;

3) remove the oral-gastric tube, optionally, the sleeve may be left inplace to protect the esophagus;

4) position the adjustable stoma over the balloon on a primarydilatation catheter;

5) insert the dilatation catheter and the adjustable stoma over theguidewire into the stomach;

6) inflate the balloon on the dilatation catheter to expand theadjustable stoma;

7) exchange the dilatation catheter and repeat if necessary to achievethe proper outer diameter;

8) suture or staple the stomach wall to approximate a gastric pouch,this can be done with open surgery, laparoscopically or, preferably,transesophageally;

9) reinflate the balloon on the dilatation catheter to grip theadjustable stoma;

10) withdraw the dilatation catheter until the adjustable stoma ispositioned within the suture line in the desired stoma position;

11) secure the adjustable stoma in place and suture, staple and/or glueto seal the adjustable stoma to the gastric pouch;

12) withdraw the dilatation catheter;

13) insert the heat application means over the guidewire and position itwithin the stoma aperture;

14) apply heat to shrink the inner diameter of the adjustable stoma;

15) withdraw the heat application means;

16) if necessary, insert a dilatation catheter and inflate the balloonto dilate the stoma aperture to the desired diameter;

17) withdraw the dilatation catheter, guidewire and orogastric tubesleeve (if used)

This method can be modified for installation of a fixed diameter stomadevice or a smart stoma device that does not require heating and/ordilatation to adjust the inner diameter of the stoma aperture. Themethod can also be modified for installation of a stoma device with aself-expanding metal lattice on the outer circumference, obviating theneed for the primary dilatation catheter. The order of the method canalso be modified, for example the pouch can be created first or theartificial stoma can be placed in a pre-existing pouch where thesurgically created stoma has become enlarged. Other methods ofattachment described herein may also be used for placement of a stomadevice.

The adjustable stoma device may be initially implanted with the stomaaperture larger than clinically useful. This would allow food to passeasily through the stoma aperture and minimizes the stress on theattachment points for the stoma device and the sutures or staplesforming the gastric pouch. This will allow the stomach wall to healbefore the stoma aperture is reduced to a clinically significantdiameter, which will naturally place more stress on the tissue and theattachment points.

Alternatively, the adjustable stoma 100 may be configured such that theinner diameter 110 is adjusted by inflation by transferring fluid from areservoir into the annulus between the inner and outer circumference.FIGS. 5A-5B show an adjustable stoma 100 with an inflatable bladder 120,pump 122 and reservoir 124 and with optional suture anchors 112.

Stapling or suturing for placement of the adjustable stoma device 100 ispreferably accomplished transesophageally with the use of a flexibleendoscope. Sutures may be placed into the muscularis, through themuscularis and/or full thickness through the muscularis and serosa basedupon the clinical situation. One method for accomplishing this involvesthe use of wire fasteners 130 that are formed with a “button” end 132and a “twist tie” end 134, which are shown in FIGS. 6A-6D. In certainembodiments, the wire fasteners 130 are formed from a superelastic NiTialloy so that the fasteners can be straightened out and passed through adelivery cannula 136, as shown in FIG. 6A. The distal tip 138 of thewire can be sharpened so that it will penetrate tissue. A portion of thedistal end of the wire is formed so that it will assume a circular orspirally curled “button” shape 132 after it has passed through thetissue, as shown in FIG. 6B. The “button” shape 132 attaches thefastener to the stomach wall and prevents it from being pulled outthrough the tissue. The curl of the “button” 132 can be shaped so thatit protects the sharpened distal tip 138 of the wire and prevents itfrom damaging the stomach wall or surrounding tissues after the fasteneris deployed. There is an approximately 90 degree bend 140 in the wirejust proximal to the “button” portion 132. A portion of the proximal endof the wire is formed to create the “twist tie” 134, which reforms whenthe wire fastener 130 is pushed out of the delivery cannula 136, asshown in FIG. 6C. The “twist tie” 134 can be a helical curl or othershape that will entangle and interlock with a mating fastener when thetwo are approximated to one another, as shown in FIG. 6D. Alternately,the proximal end 134 of the wire fastener 130 can form a loop forattachment of standard suture materials.

The delivery cannula 136, which may be configured with a torquable shaftwith a fixed or variable curve 144 at the distal end, is used to deliverthe wire fasteners 130 to the desired location. The distal end of thedelivery cannula 136 is advanced until it contacts the stomach wall,then a pusher wire or the like is used to advance the wire fastener 130through the delivery cannula 136, as shown in FIG. 6A. As the wirefastener 130 exits the delivery cannula 136, the sharpened distal tip138 penetrates the stomach wall. The “button” portion 132 of the wireassumes its curved configuration distal to the stomach wall as thefastener 130 is advanced farther out of the delivery cannula 136, asshown in FIG. 6B. These steps are repeated to place a second wirefastener 130 in the opposite wall of the stomach. Then, the two deliverycannulas 136 are withdrawn while continuing to advance the wires out ofthe delivery cannulas to allow the “twist tie” portions to assume theirhelical curled shape proximal to the stomach wall and the two fastenersare approximated to one another so that the two “twist tie” portionsintertwist with one another as they exit the delivery cannulas to attachthe two walls of the stomach together, as shown in FIG. 6D.Alternatively, the wire fasteners 130 can employ a loop, rather than a“twist tie” to enable approximation using a secondary means such assutures. A line of fasteners 130 can be thus deployed to create agastroplasty pouch or band.

In an alternate embodiment, the wire fasteners may be configured to havea “button” portion 132 on both ends of the wire. These fasteners can bedeployed laparoscopically to penetrate both walls of the stomach with a“button” 132 placed on each side of the stomach to attach the wallstogether. Such fasteners can be combined with buttressing reinforcementssuch as pledgets made from Teflon, bovine or porcine tissue or otherknow materials. “T-tag” type fasteners could be applied to this use andtype of application.

T-tag fasteners can be used to attach many of the structured describedherein. A T-tag is basically a cross member or “T” that is attached toan elongated member or tail at or near the mid-point of the T. A “stem”may be a structure at the joining point of the T and tail. T-tagfasteners are generally configured to flex at the juncture of the T andtail to allow delivery along the axis of the T through a minimalpuncture diameter. T-tag fasteners can be configured with an extendedtail that may extend out the mouth and optionally be used to parachutedevices for attachment into position in vivo. Other T-tag configurationscan include, crimp, snap, screw or other means of securing the T-tagtail when appropriate. One embodiment of a T-tag fastener could includea dual tail. Such a dual tail could be combined with extended tails thatcould then be tied out side the body with the ensuing knots thentightened within the body. Such a dual tail could be constructed of oneof a number of non-biodegradable suture materials known in the artincluding polypropylene, nylon, braided Dacron or silk. In some clinicalsituations biodegradable tails could be indicated and could beconstructed using materials described herein.

FIGS. 94A-94C illustrate a method of placing T-tag fasteners 918 throughthe gastric wall that prevents accidental damage to other structures.One method of accomplishing this end could involve the use of anendoscope 920 with two (2) working channels. One channel could be usedto deliver a grasping means 921 that would grasp the gastric wall (asillustrated in FIG. 93A) and invaginate it to displace the area graspedaway from adjoining structures (e.g. spleen). The second working channelcan then be used to deliver a T-tag fastener 918 through, for example, ahollow needle type delivery system 922 (e.g. T-ANCHOR INTRODUCER GUN(Moss Tubes)) that has been redesigned so it can be passed through theworking channel of an endoscope and then rotate 90 degrees into position(as illustrated in FIGS. 94B and 94C). Laparoscopic or otherextragastric means could also be applied to the end of preventing damageto adjoining structures.

For each subsequent T-tag fastener 918, the previously placedfastener(s) may be used to grip and invaginate the gastric wall. Thefasteners may be used to assist in forming of a plication or inretracting and positioning the gastric wall for fastening anothercomponent, such as a stoma, sleeve or attachment ring. Similarly, othergripping means, such as vacuum, transmural hooks and the like, may beused to facilitate placement of fasteners to assist in forming of aplication or in retracting and positioning the gastric wall forfastening another component of the system.

An example of a method of use of one configuration (dual tail T-tag) ofthe structures described above when used to attach an attachment ring asin FIG. 77 could be as follows:

1. Position endoscope overtube

2. Insert endoscope (2-channel) and, using grasper and T-tag deliverydevice, deploy a T-tag and position the T-tag tails externally (Repeat 6times)

3. Pre-thread T-tag tails through an attachment ring matching each pairof the 2-tailed T-tags to capture a predetermined portion of theattachment ring material

4. Prepare to parachute the attachment ring through over tube and passthe ring through overtube.

5. Snug T-tag tails to position attachment ring and ready for finalattachment

6. Using appropriate instruments partially tie the knots externally andadvance the partial knots into position to be secured and trimmed(Repeat 6 times)

7. Remove all instrumentation

The final result is now illustrated as FIG. 91A. This attachment methodcan be modified by the use of multiple rows of T-tag fasteners asdescribed herein.

Peroral extra-gastric buttress reinforcement—Buttresses are preferablyplaced in locations subject to forces to which there will be clinicalbenefit to distributing forces. The buttressing material is generallyconfigured perpendicular to the axis of the attachment means (e.g.suture, rivet or staple) and therefore best distribute forces along theaxis of the attachment means. When a device is attached to theintragastric wall such forces can be directed inward from the gastricwall. Therefore, if the buttress is attached to the intragastric wall,the buttress may not be along the axis best suited to resist the appliedforce.

Many of the apparatus and methods described herein use a plication toredirect these forces to allow intragastric buttresses to distributethese forces in a beneficial, i.e. more perpendicular, direction. Otherapparatus and methods described use other structural means to distributeforces on the extragastric wall in which case inwardly directed forceswould be in a beneficially perpendicular direction. The followingdescribes an exemplary apparatus and method to embody and deliverextragastric buttresses.

Use of a curved needle to deliver a buttress that, in one configurationis a teflon pledget, to a location on the extra gastric wall from theinside of the stomach. This pledget would be captured in an invaginating(into the stomach) plication that could then be secured by sutures,staples, rivets et al. The buttress could be a tubular shapes segment ofexpanded teflon similar to a small diameter vascular graft. This couldbe delivered on the outside of a curved needle, which, upon withdrawalretrograde from the direction of delivery, would leave the pledget inposition outside the stomach. The plication would be preferably securedprior to the removal of the needle. The buttresses could be delivered ina similar manner through the lumen of a hollow needle. In this case itmay be preferred to partially withdraw the needle and deploy thebuttress prior to securing the plication.

This system, as can others described herein, could use 4-10 or moreprimary fixations to resist tension and optionally use intermediatesutures, rivets, etc. if appropriate to resist leaks.

Fastener (T-tag) buttress (T-pledget) method and structure—An alternatemethod of delivering these buttresses would be using a T-fastener(T-tag) where the “T” portion was constructed of a material withproperties that would be useful as a buttressing material. This would bea T-tag buttress or a T-tag pledget. Hereinafter T-pledget. These T-tagscould be delivered through a hollow needle type delivery system (e.g.T-ANCHOR INTRODUCER GUN (Moss, Moss Tubes)) that has beenredesigned/modified so it can be passed through the working channel ofan endoscope. One advantage of the use of T-pledget is that a T-tag canbe designed with an elongated tail that can extent out through the mouthand be used to parachute structures into place in-vivo. T-pledget tailscould include preloaded needles. Needles could be curved or straight.

The suture, staple, rivet or other fastener used to secure the sleeveattachment ring or other device into place could, based upon theclinical situation, capture the pledget portion of the T-pledget to fixit in place in relation to the attachment means.

A method of use of one configuration of the T-pledget structuresdescribed above when used to attach an attachment ring could be asfollows:

1. Position endoscope overtube

2. Insert endoscope (2-channel) and using grasper and T-pledget, deployT-pledget and position tails externally

3. Pre-thread T-pledget tails through attachment ring

4. Prepare to parachute attachment ring through over tube and pass thering through overtube

5. Snug T-pledget tails to position the ring and ready for finalattachment

6. Using tails, guide the PLICATOR (NDO Surgical Inc.) into position andfire the PLICATOR to form a plication over the T-pledget

7. Trim tails and remove all instrumentation

The final result is now illustrated as FIG. 91B (showing a dualattachment face ring as described below).

T-pledgets can be structured using a variety of means. A portion ofstandard Teflon pledget material can have a suture tied or otherwiseattached, at or near its mid point. This can be structured or otherwiseprepared for delivery by means such as rolling and/or compressing tofacilitate passage through tissue with a minimum disruption of thetissue layer. Ideally the T-pledget would have a minimum diameter whenpassing through tissue. Depending upon the clinical situation varyingdeployed diameters/areas could be preferred. A hollow needle or otherhollow tube can be used to facilitate passage through tissue. Structureand/or material selection to enhance axial rigidity along the axis ofdelivery will be beneficial is some clinical situations. A piercingpoint on the leading edge of the “T” may be useful with some delivermechanisms.

Many of the features described above can be achieved with constructionusing a single piece of Polypropylene, Nylon, or other polymericmaterial well known in the art for use in construction sutures, whichforms the “T” and tail as a single unit. Alternately 2 differentmaterials can be combined, for example by insert molding, to achievedifferent properties of the “T” and tail. In another embodiment thiscould be combined with a “T” portion that is coated with a materialselected for specific clinical properties such as encouraging ordiscouraging either in-growth or adhesion. The “T” portion may also besurrounded by another material such as Teflon pledget material or Dacrongraft material. “T” diameter will vary according to the material usedfor example ranging from 0.5 mm to 3.0 mm in diameter for nylon orpolypropylene with the typical “T” having a diameter of 1-2 mm. A tailcould be the dimension of a standard suture and could generally varyfrom 5-0 to 0 (USP standard classification) though smaller or largersizes may be appropriate in certain clinical situations.

In one configuration that could have advantages in certain clinicalsituations the “T” and/or tail portions of the T-pledget could beconstructed in part or in toto of a biodegradable material as describedherein. In one such configuration the “T” portion would be constructedof a flexible buttress material that is not biodegradable. In someembodiments this could have a tubular configuration. This would includea core of a more rigid material that is biodegradable. The tail in thissituation could be optionally biodegradable. This combination T-pledgetcan have advantages in that its “T” portion will 1) have increasedrigidity for insertion; 2) maintain its ridgidity during the time periodwhile the tissue goes through its healing period and ideally until itregains its strength; and 3) become softer and more flexible to minimizethe potential for erosion over the length of time the pledget is inposition. Various buttress materials, both biodegradable and not, aredescribed herein.

In an alternative embodiment a porous buttress material could beimpregnated with a biodegradable material to achieve a similar result.Similarly a biodegradable material could coat a buttress material. Therigidity of both the permanent buttress material and the biodegradablematerial may be selected and modified to suit specific clinicalsituations. In some situations the biodegradable material may be of alesser rigidity compared to the buttress material. Embodiments thatinclude a biodegradable tail portion could have an advantage in certainclinical situations, as this would eliminate the tail as a focus for aleak after it has degraded. Bioresorbable materials such aspolyglecaprone (Monocryl, Ethicon), polyglactin (Vycril, Ethicon) orother as well know in the art can be appropriate for use in theseapplications.

Bio-stable, solvent dissolvable pledget material—In other situations thepledget material could be made from a material that is stable in thebody but could dissolve in the presence of a biocompatible solvent, or abiocompatible solution including a chemical or catalyst that willinitiate the pledget's dissolution. This would allow simplified removalof the pledget material via lavage of the peritoneum if the stomachattachment means were to be released through an endoscopic procedure orwere otherwise desirable based upon the clinical circumstances.

Dual attachment faces and T-tag or T-pledget extra-gastric buttressreinforcement—As illustrated in FIG. 91B, in one embodiment ofattachment to a plication, the structure of the device being attachedcan include attachment faces that capture both sides of the plicationthereby forming a buttressing means for the means used to secure theplication.

As discussed herein, forces can be applied inwardly by devices attachedto the intragastric wall. Other forces are applied to the gastric walldue to the natural muscular action of the gastric wall. These forces canserve to be applied in the plane of a gastric wall and, in this case,can serve to apply tension to separate a plication. Use of a T-pledgetas an extragastric buttress in combination with a device that includesattachment faces that capture both sides of the plication as shown inFIG. 91B can be particularly beneficial in resisting these forces.

Dual attachment faces 926 can be integrated with the ring, or otherattachment means, used to secure other devices, e.g. a sleeve, to thestomach or they could be separable to facilitate delivery, attachmentand/or removal. If separate, the ring can optionally include structuressuch as holes or other guide means that would facilitate parachuting thedevice into position. These attachment faces can be made of materialsthat either encourage or discourage in-growth and/or epithelializationas dictated by the clinical situation. Dual attachment can also be usedwithout extragastric buttressing.

Use of attachment face materials and buttress materials that discouragein-growth along with securing means that initiate minimal scar formationcould enhance the reversibility of the procedure if and when thesecuring means were to be released and removed. Attachment faces, alongwith any structures attached to or incorporated within, could then besloughed and passed naturally and/or removed via a transoral route asindicated by the device and the clinical situation. Use of an overtubeto protect the esophagus during transoral removal of certain devices canbe clinically indicated based upon the size and shape of the devicebeing removed.

The concept of using attachment faces that capture both sides of aplication can be applied to other attachment means described herein. Theconcept of using one or more separable attachment faces as a means tocapture other devices can optionally be applied to other attachmentmeans described herein.

A method of use of one configuration of the structures described abovecould be as follows:

1. Position endoscope overtube

2. Insert endoscope (2-channel) and using grasper and T-pledget device,deploy T-pledget and position tails externally (Repeat 6 times)

3. Pre-thread T-pledget tails through attachment face material (and, ifused, thread through separate sleeve ring)—Note that the tails arepassed through the attachment face material at a location that willprovide for an appropriate amount of attachment face material on eitherside of the plication as indicated by the clinical situation.

4. Prepare to parachute devices through over tube and pass device(s)through overtube

5. Snug T-pledget tails to position device(s) and ready for finalattachment

6. Using tails, guide the PLICATOR (NDO Surgical Inc.) into position andfire the PLICATOR to form a plication over the T-pledget (Repeat 6times)

7. Trim tails and remove all instrumentation

In an alternate example of the above-described method using a dual tailT-tag or a T-tag device with securing structure, step 6 can be replacedwith tying or otherwise securing each T-tag as the final attachment.

In a similar manner to a T-pledget, a pledget can be delivered to theextragastric surface using an expanding tip configuration similar to a2-wing Malecot catheter. The expandable Malecot tip would be detachablefrom its delivery cannula.

In this case the Malecot pledget could include:

1. a pointed distal tip for penetration through the gastric wall (notein some embodiments this tip may be dissolvable to reduce the potentialfor long term tissue irritation)

2. a suture-like tail attached to distal tip (to retract and expand thetip)

3. a method that would include applying tension to the suture tail toexpand the tip after it has been positioned beyond the extragastricsurface

4. a delivery cannula that can support the proximal portion of thepledget (support to translate suture retraction into pledget tipexpansion)

Retraction of the delivery cannula/pusher would leave the expandedMalecot pledget on the extragastric surface.

In-line pledget (alternative to curved needle delivery)—In this case thepledget material would be in line and coaxial with the suture. Thepledget would include at least one tapered end for passage throughtissue and may be expandable over time (to allow a small hole or passagethrough the tissue and a greater buttress area). The needle on the endof the suture would be passed through the gastric wall twice (firstinside-to-outside and then, approximately a pledget's length apart,outside-to-inside). This could be accomplished with laparoscopicassistance; a large radius curved needle or other means. The suturewould be advanced until the pledget is in position and excess suturewould be trimmed. The suture could be biodegradable.

T-tag 918 and T-pledget 920 embodiments designed for expandability—AT-tag or T-fastener can be used to provide knot free means to applytension to a suture and an associated anatomic structure. A furtheradvantage of a T-tag is that the forces applied to the suture tail ofthe “T” are distributed over a larger area than a single stitch. This isaccomplished by using a “T” dimensioned with a width wider than thediameter of the suture and a length longer than a typical bite orstitch. A disadvantage of a T-tag is that insertion of a T-tag throughtissue requires a hole many times, for example 5-15 times, the diameterof the suture tail.

To deliver an improved buttressing capability in a T-tag fastener orT-pledget with a minimum delivery hole it is beneficial to use a “T” orpledget designed to expand after delivery. This can be beneficial inmany clinical situations. In addition to rolling or compressing,alternate structures can include materials that expand when exposed towater such as hydrogels. FIGS. 93C and 93D show how a T-pledget 920 orT-tag 918 of woven cylindrical meshes that may be compressed orelongated to achieve a reduced diameter and expanded or shortened tobecome wider. Compared to a rectangular sheet, alternate configurationsof a rolled and unrolled sheet can achieve a T-pledget 920 or T-tag 918with increased projected width relative to its rolled diameter throughthe use of matching cutouts, as shown in FIGS. 93A and 93B. Though notas efficient in diameter-to-projected width ratio, is some cases it maybe clinically desirable to have a “T” that is in a circular shape.

To resist bending perpendicular to the axis of the suture, it may bebeneficial to use metals, for example Ti, SS or NiTi. In some clinicalsituations, encapsulating or coating the metal with a fluoropolymer orother coatings as described herein may also be beneficial.

T-tag with inflammatory reaction or other additives—The pledget materialcould be optionally coated or impregnated with materials and/ormedicaments as described herein. For example the pledget can be coatedwith a material that would enhance inflammation and scar formation.Alternatively, a coating or medicament that would either encourage ordiscourage in-growth can be applied.

In some clinical situations it may be beneficial to use both these typesof coatings. For example, though inflammation can lead to scarringfibrosis and ultimately strengthen tissue, the inflammatory processinitially results in tissue weakening that can include tissueliquefaction. Therefore, it can be desirable that a fastener thatinduces an inflammatory response for long term strength also includemeans to support the tissue during the weakened stage.

Inflammatory reaction materials would be limited to a portion of theT-tag or T-pledget as the inflammatory response weakens tissue beforethe scarring fibrosis occurs. Therefore, for example, having the area atthe center of the T or pledget with this inflammatory material and theends of the “T” without this material could have an optimized balance ofshort term and long term strength.

Drug-eluting coatings may be used to encourage or discourage tissueingrowth into the fasteners or other device attachment mechanismsdescribed herein. A low inflammatory response is generally desirable forencouraging tissue ingrowth. Anti-inflammatory drugs that may be usedinclude steroidal anti-inflammatory drugs, e.g. prednisone, andnonsteroidal anti-inflammatory drugs (NSAID), e.g. chromalin.Conversely, drugs that may be used to control or reduce tissue ingrowthinclude Taxol (paclitaxel) (Bristol-Myers Squibb) and Sirolimus(rapamycin) (Wyeth-Ayerst Laboratories).

Embodiments designed for improved erosion resistance—The purpose of the“T” in a T-fastener is to distribute and resist the forces that couldact to pull it through tissue, in this case the gastric wall. To betterachieve this result the “T” should resist bending. Though a T-fasteneris generally held parallel to the surface of the extragastric wall, atthe ends of the “T” the gastric wall extends outward from the plane ofthe surface and the axis of the “T”. In this case, the gastric wallcould be at a 90-degree angle, or greater, to the ends of the “T”. Toreduce the potential for erosion at the end of the “T” in some clinicalsituations it could be beneficial for the ends of the “T” to haveincreased flexibility which will result in a reduction of the anglebetween the gastric wall and the ends of the “T”. This would reduce theforces between the “T” and the gastric wall and therefore reduce thepotential for erosion at the ends. Structures that could accomplish thiscould include tapered thickness or cross section to reduce the bendingmoment. Alternatively or in addition, changes in material propertiessuch as hardness, bending modulus and/or elongation can accomplish thesame result. For example the “T” near the stem could be of a material ofa durometer such as Shore 65D or higher the material may change as onemoves out along the arms of the “T” transitioning through 55D/100 A to90 A durometer or lower. Rounding, smoothing and structures thatotherwise distribute forces over a larger area will also serve to reduceerosion at the ends of the “T”. A circular shaped “T” may beparticularly desirable to reduce erosion.

Another method of intragastric stapling utilizes a pair of vacuum ormechanical graspers to capture the tissue to be joined, for example thestomach wall. The graspers approximate the tissue and present it to astapling mechanism. Once the tissue has been presented to the staplingmechanism, a number of methods may be used:

1) a staple or clip may be applied to join the tissue together;

2) a precurved wire fastener, which may be constructed of a NiTi alloyor other material, may pierce the tissue on one side and then pierce thetissue on the other side as it curls to capture both;

3) a curved needle with attached suture can be passed through the tissueusing known endoscopic suturing techniques.

These two methods (vacuum approximation and NiTi buttons) can also becombined.

Intra gastric stapling can be facilitated by external manipulation in acombined endoscopic/laparoscopic approach. Internal endoscopicmanipulation can be combined with external laparoscopic stapling orexternal manipulation can be combined with internal endoscopicmanipulation. Laparoscopic techniques can also be used inside thestomach.

In an alternative embodiment, the stoma may be a self-adjusting “smartstoma” that opens and/or closes in response to stomach conditions. FIGS.7A-7B show an enlarged view of a smart stoma device 150 with a stomaaperture 152 that varies its diameter in response to conditions in thepatient's stomach. In one embodiment shown in FIGS. 7A-7B, the smartstoma device 150 includes a fluid-filled bladder 154 surrounded by anosmotic membrane 156. One example of a suitable material for the osmoticmembrane 156 is silicone (e.g. Dupont Silastic). The osmotic membrane156 may be made of microporous silicone or other material similar tothose used for hemodialysis membranes. In response to changingconditions, for example if the patient drinks a glass of water, waterwill move across the osmotic membrane 156 to swell the bladder 154 andshrink the stoma aperture 152 to restrict food intake.

In another embodiment shown in FIG. 8A-8B, the smart stoma device 150may include a toroidal member 158 made of a swellable material, such asa hydrogel (e.g. Akina HydroTab). In response to changing conditions,for example if the patient drinks a glass of water, the toroidal member158 will swell and shrink the stoma aperture 152 to restrict foodintake. Alternately the hydrogel can expand in the presence of aspecific chemical such as the glucose sensitive hydrogel material usedin the Glucose Biosensor (M-Biotech)

FIGS. 9A-9B show an enlarged view of a smart stoma device 150 with aclosed loop controlled variable diameter stoma aperture. Similar to theembodiment shown in FIGS. 7A-7B, this smart stoma device 150 includes afluid-filled bladder 154 surrounded by an osmotic membrane 156. A firstelectrode 160 is connected to the osmotic membrane 156. The firstelectrode 160 and a ground electrode 166 placed elsewhere on the bodyare connected to a voltage source 162 such as a battery via a controlcircuit 164. When a voltage is applied between the first electrode 160and the ground electrode 166, it increases the flow rate across theosmotic membrane 156 to quickly swell the bladder 154 and shrink thestoma aperture 152 to restrict food intake. Note that the polarity ofthe circuit in FIGS. 9A-9B is for reference only and can be alteredbased on material selection and fluid polarity. Similarly this type ofstoma can use a polyacrylic acid hyrdogel which responds to appliedpositive polarity field by contracting and expelling water. The stomadevice 150 may be configured to operate automatically in response tochanging conditions, for example the control circuit 164 may include asensor 168 for sensing water or certain nutrients, such as sugar, or anactivity related to ingestion, such as swallowing or gastric response.Alternatively, the stoma device 150 may be configured to be remotelyoperated in response to a control signal from outside of the patient'sbody.

Alternatively, the artificial stoma may be anchored with a suturelessattachment that does not penetrate the esophageal or stomach wall.Sutureless attachment mechanisms may be used in conjunction with any ofthe stoma configurations discussed herein. FIGS. 10A-10C show anartificial stoma device 170 with a sutureless anchoring mechanism 172.The stoma device 170 has a retracted/compressed position wherein thestoma device 170 and the anchoring mechanism 172 have a small diameterthat can easily pass through the patient's esophagus into the stomach,as shown in FIG. 10A. The stoma device 170 may be introduced mounted ona flexible endoscope or on a separate insertion device. Once the stomadevice 170 is in the selected position in the stomach or loweresophagus, the sutureless attachment mechanism 172 is actuated to expandand hold the stoma device 170 in place, as shown in FIGS. 10B and 10C.

In one embodiment, the sutureless attachment mechanism 172 may beconfigured as an expandable wire stent that expands against the stomachor esophageal wall to hold the stoma device 170 in place. Preferably,the expandable wire stent is surrounded by an elastomeric membrane orthe like to prevent leakage of liquids or food past the stoma device170. The surface of the membrane may be treated to encourage tissueingrowth to permanently anchor the stoma device 170 in place.Alternatively, or in addition, the sutureless attachment mechanism 172may include hooks or barbs that pierce the tissue for additionalanchoring. Such hooks or barbs may have an undeployed position in whichthey lie against the device and a deployed position in which they rotateor extend outward to grip the tissue. The stomach wall should bepositioned such that the attachment mechanism 172 will grip the stomachwall when it is actuated.

In an alternative embodiment, the stoma device 170 may be configured tohave a reversible sutureless attachment mechanism 172 for temporaryimplantation of the device. A reversible sutureless attachment mechanism172 may have two modes of attachment, a temporary mode and a permanentmode. Thus, a stoma device 170 can be implanted in a patient's stomachfor a trial period using the temporary attachment mode. After the trialperiod, if the therapy has been ineffective or if the implant was notwell tolerated by the patient, the stoma device 170 can be removed. Onthe other hand, if the therapy has been effective and the implant iswell tolerated by the patient, the stoma device 170 can be permanentlyattached by actuating the permanent attachment mode or simply leavingthe implant in place to allow permanent attachment and tissue ingrowthto take place.

Preferably, the stoma device is constructed with radiopaque and/orsonoreflective materials and/or includes one or more radiopaque and/orsonoreflective markers for enhanced imaging by X-ray, fluoroscopy and/orultrasonic imaging so that the position and functional state of theimplanted stoma device can be verified noninvasively in addition toendoscopic direct visualization.

In another aspect, the system may include an internal gastric sleeve 200that may be used separately or used with, attached to or integrated withthe artificial stoma component 100. FIG. 11 shows a gastric sleevedevice 200 with an artificial stoma device 100 implanted within apatient's stomach. Optionally the sleeve can be attached to the outletof a surgically created stoma or pouch that does not include anartificial implanted stoma. The gastric sleeve device 200 may include apyloric sleeve anchor 202 for anchoring the distal end of the sleeve 200in the region of the pylorus. The pyloric sleeve anchor 202 can beconfigured with openings 214 to allow digestive secretions to passthrough the pylorus into the small intestine. The internal gastricsleeve 200 effectively reduces the volume of the stomach because theflow of solid food is limited to the lumen of the sleeve 200. The entiregastric sleeve 200 or a portion of it can be porous or semipermeable toallow the flow of digestive secretions into the sleeve and to allow theflow of nutrients and/or fluids out through the wall of the gastricsleeve 200. Porosity can be achieved for example by forming holes in thesleeve using a laser or mechanical means. Semipermeable areas of thesleeve can be formed, for example, from silicone or materials used forhemodialysis membranes.

Pyloric anchors can be fixed to a predetermined location on the sleeveor be mobile. For example, a pyloric anchor could be slidable and slidinto place before it is fixed to a structure on the sleeve. Structuresfor anchor fixation could include reinforcement and/or structures suchas snaps, loops and/or holes to facilitate attachment of the anchor tothe sleeve. Slidable or other structures that allow positing of ananchor can be used to set the distance between the attachment of thesleeve near the GEJ and the support or strain relief provided by theanchor at the pylorus. This distance can be set prior to placement ofthe device, based upon fluoroscopic or other measurements or in vivo. Ifthe distance is set in vivo, structure could be provided to allowfixation using commercially available tools such as ENDOCINCH (Bard),ENDOSCOPIC SUTURING DEVICE (Wilson-Cook Medical) or PLICATOR (NDOSurgical Inc.) or an endoscopic grasper. Alternately, a structure thatrequires a special attachment device, such as the riveters describedherein could be used.

In some clinical situations it could be beneficial to have an anchordesigned to allow motion. This could include some means to bias theanchor to return to a predetermined location relative to a set positionon the sleeve. This could be accomplished by incorporation of a spring,elastomeric structure or other such biasing structure.

FIGS. 12A-12E are detail drawings showing additional features of agastric or intestinal sleeve device. FIG. 12A shows a detail drawing ofa gastric and/or intestinal sleeve device with openings 204 through thesleeve wall. Valves 206 may be provided in the wall of the gastricsleeve to allow digestive secretions to enter the sleeve, but to preventsolid food and/or nutrients from flowing out through the wall of thesleeve. FIG. 12B shows a detail drawing of a gastric and/or intestinalsleeve device with valved openings 206 through the sleeve wall. Examplesof valves for this application include slit and flap type valves.Alternatively, the entire gastric sleeve 200 or a portion of it can benonporous or impermeable to act as an internal gastric bypass. FIG. 12Cshows a detail drawing of a gastric and/or intestinal sleeve device withporous sections 216 in the wall of the sleeve. FIG. 12D shows a detaildrawing of a gastric and/or intestinal sleeve device with slits 218 inthe wall of the sleeve. FIG. 12E shows a detail drawing of a gastric orintestinal sleeve device with artificial cilia 230 on the interior ofthe sleeve wall. The artificial cilia 230 facilitate the flow of foodthrough the sleeve. Artificial cilia could be created by brushing orabrading the interior surface of the sleeve in the direction of foodflow. This can raise a nap in the surface of the material biased to thedirection of the abrasion. Alternatively, for example, the cilia couldbe molded into the surface of the sleeve. Alternatively or in addition,a hydrogel coating (for example polyvinyl pyrrolidone, hydromer) orother lubricious coating (for example PHOTOLINK LUBRICIOUS COATING,Surmodics Inc.) may be used to facilitate the flow of food through thesleeve.

The proximal (food entry) opening of the gastric sleeve is dimensionedto correspond to the opening of the esophagus, pouch outlet orartificial stoma. The outlet of the esophagus is generally free ofrestrictions to food passage while pouch outlets and stomas which are insome cases configured to restrict the passage of food. These outlets orstoma are generally less than 10-40 mm in diameter and, if restricted,are typically 15 mm or less. This distal end of the sleeve is reinforcedand/or configured for attachment to the gastric wall, surgical orartificial stoma opening. This opening for attachment is preferablyslightly larger than the diameter of the restricted opening. Past theattachment to the opening the sleeve itself is typically 20-40 mm indiameter with a smooth transition from the opening diameter to the maindiameter. If the sleeve continues past the pylorus, at the pylorus thisdiameter may remain the same, or may reduce to a smaller diameter on theorder of 10-20 mm. The sleeve should not be in sealing contact with thestomach wall or the pylorus to allow free passage of gastric secretionsalong the outside of the sleeve as described herein.

In certain embodiments, the wall of the gastric sleeve 200 is flexibleto allow the peristaltic motions of the stomach to effect movement offood through the gastric sleeve 200. For example, blow molded 90 Adurometer polyurethane of a wall thickness on the order of 0.005″ willwork in this manner. Other suitable materials for construction of thegastric sleeve device 200 can include fluoropolymers, silicone andpolyurethane. Some fluoropolymers can be thermoformed (e.g. PFA and FEP)while others such as PTFE can be expanded in a similar manner to theformation of a vascular graft as well known in that art. Silicone (e.g.Dow Silastic or similar material from Nusil Technologies) orpolyurethane (e.g. Dow Pellethane) can be dip molded or cast.Polyurethane can also be blow molded. In some embodiments the wall ofthe sleeve may be reinforced with rings or a spiral made of wire and/orplastic to hold the sleeve open. FIG. 13 shows a detail drawing of agastric and/or intestinal sleeve device with reinforcement rings 208.The reinforcement rings 208 are spaced apart at intervals along thelength of the sleeve and the sleeve may include one or more longitudinalribs 210 linking the reinforcement rings together along the length ofthe sleeve. FIG. 14 shows a detail drawing of a gastric and/orintestinal sleeve device with a spiral reinforcement 212. Thereinforcement rings 208 or spiral reinforcement 212 should be resilientenough that peristaltic motions of the stomach and/or intestines can betransmitted through the wall of the sleeve with the sleeve springingback to its full diameter after the peristaltic contractions. Theresiliency of the reinforcement rings 208 or spiral reinforcement 212also allows the sleeve to be collapsed to facilitate endoscopicplacement of the device. The reinforcement rings 208 or spiralreinforcement 212 may be made of or supported with stainless steel or asuperelastic or shape-memory NiTi alloy. The reinforcement rings 208 orspiral reinforcement 212 can also be plastic. The reinforcement rings208 or spiral reinforcement 212 may be sized to fit loosely within thestomach or intestines or to provide a little bit of contact force tocreate a seal with the intestinal walls. As described herein in relationto the intestinal sleeve, it is important to control the coupling offorces that are transmitted by the action of the stomach (in this case)to the sleeve. Transmission of excessive force to the stomach attachmentcan be contraindicated in many clinical situations and in this case thecoupling should be minimized. This can be accomplished, for example,through the use of low friction coatings on the sleeve exterior, usingsoft compliant (e.g <70A durometer non-metal reinforced) reinforcingrings and/or by not using reinforcing rings.

The interior and exterior of the sleeve can optionally be coated with alow friction material as described herein (e.g. a hydrogel) to reducefriction of food passage (interior) and reduce gastric irritation(exterior). The interior of the sleeve can optionally include flexibleprongs angled toward the direction of food flow to act as artificialcilia and resist food moving retrograde along the sleeve, as shown inFIG. 12E. Optionally the distal end of the gastric sleeve canincorporate an enlarged reservoir portion proximal to the pylorus.Optionally the sleeve can include coatings on its interior and/orexterior to enhance the surface properties of the sleeve in clinicallyrelevant manners. Coating examples include: 1) parylene coatings toincrease the chemical resistance of a sleeve material, 2) coating withan antimicrobial agent to resist infection and/or 3) coating with ananti-inflammatory agent to reduce tissue inflammatory response, asdescribed herein.

In conjunction with the gastric sleeve 200, the volume of the stomachcan be reduced by suturing, stapling or banding using open,transesophageal or laparoscopic techniques. In the example shown in FIG.10, a vertical line of gastroplasty sutures or staples 104 parallel tothe sleeve 200 has been used to reduce gastric volume. Alternatively orin addition, a horizontal line of gastroplasty sutures or staples may beused to form a reduced volume gastric pouch. The sutures or staples mayor may not be in a continuous line and may or may not be reversible. Thestomach can also optionally be divided at the gastroplasty. Theseadjunctive techniques may assist in enhancing the effect of peristalticmotions of the stomach for moving food through the gastric sleeve.

Alternatively or in addition, a gastric balloon or other volumedisplacement device may be used in conjunction with the gastric sleeveto provide a feeling of satiety.

Preferably, portions of the gastric sleeve are constructed withradiopaque and/or sonoreflective materials and/or includes one or moreradiopaque and/or sonoreflective markers for enhanced imaging by X-ray,fluoroscopy and/or ultrasonic imaging so that the position andfunctional state of the implanted gastric sleeve can be verifiednoninvasively. However, the sleeve should not be completely radiopaqueto allow visualization of the passage of ingested radioopaque contrastas in a “swallow” study.

In another aspect, the system may include an internal intestinal sleeve300 that may be used separately or used with, attached to or integratedwith the internal gastric sleeve 200 and artificial stoma component 100.FIG. 15 shows a combined gastric 200 and intestinal 300 sleeve devicewith an artificial stoma device 100 implanted within a patient's stomachwith a line of gastroplasty sutures or staples parallel to the sleeve104. The entire intestinal sleeve 300 or a portion of it can be porousor semipermeable to allow the flow of digestive secretions into thesleeve and to allow the flow of nutrients and/or fluids out through thewall of the sleeve. Suitable materials for construction of theintestinal sleeve device 300 include fluoropolymers, silicone (e.g. DowSilastic or similar material from Nusil Technologies) and polyurethane(e.g. Pellethane). For example, in one embodiment the intestinal sleevedevice 300 may be constructed of blow molded 90 A durometer polyurethanewith a wall thickness on the order of 0.005″. Some fluoropolymers can bethermoformed (e.g. PFA and FEP) while others such as PTFE can beexpanded in a similar manner to the formation of a vascular graft aswell known in that art. Openings 204 may be provided through the wall ofthe sleeve, as shown in FIG. 12A. Valves 206 may be provided in the wallof the intestinal sleeve to allow digestive secretions to enter thesleeve, but to prevent solid food and/or nutrients from flowing outthrough the wall of the sleeve, as shown in FIG. 12B. Alternatively, theentire intestinal sleeve or a portion of it can be nonporous orimpermeable to act as an internal intestinal bypass. Valve and porositystructures to allow flow such as those described herein in relationshipto the gastric sleeve can also be applied to the intestinal sleeve. Incertain embodiments, the wall of the intestinal sleeve 300 is flexibleto allow the peristaltic motions of the intestinal wall to effectmovement of food through the intestinal sleeve. The interior andexterior of the sleeve can optionally be coated with a low frictionmaterial (e.g. a hydrogel) to reduce friction of food passage (interior)and reduce intestinal irritation (exterior). Other coatings such asthose described herein in relationship to the gastric sleeve can also beapplied to the intestinal sleeve. The interior of the sleeve canoptionally include flexible prongs angled toward the direction of foodflow to act as artificial cilia and resist food moving retrograde alongthe sleeve, as shown in FIG. 12E. The wall of the sleeve may bereinforced with rings 208 or a spiral 212 made of wire and/or plastic,as shown in FIGS. 13 and 14. Optionally the intestinal sleeve caninclude means for stabilization at the distal end such as a brush (asdescribed by Berry), weight or inflatable balloon.

The intestinal sleeve diameter can be 10-40 mm, but it is typically15-30 mm with an optional smaller diameter at the point the sleevepasses through the pylorus (if the sleeve passes through the pylorus).The diameter of the sleeve is optionally selected to be smaller that thediameter of the intestine. The sleeve should not be in permanent sealingcontact with the intestinal wall or the pylorus if it is intended tocontrol or allow passage of gastric, biliary, pancreatic and intestinalsecretions along the outside of the sleeve.

Optionally, the intestinal sleeve 300 may have a proximal end with areinforced anchoring segment or other anchoring mechanism for attachmentin the region of the pylorus or the proximal end of the intestinalsleeve 300 may be attached to a stoma device or surgically created stomaat the outlet of a reduced stomach. Alternatively, the intestinal sleeve300 may be attached to or continuous with the internal gastric sleeve200. Optionally, the distal end of the intestinal sleeve 300 may includean anchoring mechanism. FIG. 16 shows a combined gastric 200 andintestinal 300 sleeve device with an artificial stoma device 100 locatedwithin a sleeve entry 180 with a reinforced suture area 182. The sleeveentry 180 creates a reduced-volume pouch within the patient's stomachthat functions similarly to a surgically created gastroplasty pouch.

The intestinal sleeve 300 is typically approximately 60-180 cm inlength, whereby partially digested or undigested nutrients exit from thesleeve into the jejunum where they can elicit a hormonal, neural and/orosmotic reaction in the jejunum and/or ileum. However, sleeve length canbe either shorter or longer depending on clinical needs. Increasing thelength of the sleeve can increase the degree of response in the ileumwhile reducing the length of the sleeve can have the opposite effect.

In relation to the example of the placement of a stoma 100 implantedinto a surgically formed pouch described above, the gastric sleeve 200and/or intestinal sleeve 300 may be implanted according to the followingmethod:

Sleeve Placement

At any point in the procedure for stoma implantation described above,preferably prior to suturing of the gastric pouch (step 8), a gastricand/or intestinal sleeve device may be placed in the stomach and/orintestines. The distal end of the intestinal sleeve is placedendoscopically approximately 100 cm distal to the pylorus (for anintestinal sleeve with a nominal length to be 100 cm past the pylorus asdefined by the relative position of the end of the gastric sleeve 200).The proximal end of the sleeve is attached, then the gastric pouch issutured or stapled and the stoma placement procedure is resumed at step9. Alternatively, the gastric and/or intestinal sleeve device may beplaced after a pouch is formed and the stoma is placed, provided thestoma opening is sufficiently large to allow passage and manipulation ofthe sleeve and visualization apparatus. In the case of an intestinalsleeve, the proximal end would optionally be attached at the outlet ofthe stomach or at the pylorus. In the case of a gastric sleeve orcombined gastric and intestinal sleeve, the proximal end wouldpreferably be attached to a stoma device or surgically created stoma.Alternatively, the sleeve can be attached to the stomach or esophagealwall. In situations where it is desirable for the distal end of thesleeve to be placed further than 100 cm distal to the pylorus, or as analternative means of placement, the sleeve will be inserted in acollapsed configuration through the pylorus and restrained in thecollapsed configuration by a bioabsorbable/dissolvable means and passedthrough the intestines by the normal peristaltic action of theintestine. Optionally a balloon, ring or other means of increasing thecoupling of the peristaltic action to the sleeve may be attached at thedistal end of the sleeve. This is similar to the use of peristalticaction for passage of a Baker, or other long intestinal, tube as know inthe art. Rings and/or other means of increasing the coupling of theperistaltic action may be placed at other locations along the length ofthe intestinal sleeve if clinically appropriate. In some clinicalsituations a method of use whereby the resiliency of the peristalsisrings can be selected to allow the intestines to use the rings in themanner of a ladder. In this case the intestine essentially crawls up thesleeve and takes on a pleated bellows like configuration. This can havethe result of effectively lengthening the sleeve as food would now exitthe sleeve at a more distal location within the intestine.

In an alternative method, the gastric and/or intestinal sleeve devicemay be used with a stoma device placed using standard surgicaltechniques, with a surgically created stoma, with surgical gastricbanding or it may be used alone with no stoma device at all.

Preferably, portions of the intestinal sleeve are constructed withradiopaque and/or sonoreflective materials and/or includes one or moreradiopaque and/or sonoreflective markers for enhanced imaging by X-ray,fluoroscopy and/or ultrasonic imaging so that the position andfunctional state of the implanted intestinal sleeve can be verifiednoninvasively. However, the sleeve should not be completely radiopaqueto allow visualization of the passage of ingested radioopaque contrastas in a “swallow” study.

FIG. 17 shows an artificial stoma device 100 implanted within apatient's stomach with a line of gastroplasty sutures or staples 104 toreduce the gastric volume. Also shown is a line of sutures or staples304 longitudinally dividing the small intestine to create abile/pancreatic channel 308 separate from the intestinal lumen 310. Thebiliopancreatic channel 308 serves to prevent the patient's bile frommixing with the food in the intestinal lumen 310, thus reducing thedigestion and absorption of fat.

FIG. 18 shows a cross section of the patient's small intestine showingthe bile/pancreatic channel 308.

FIG. 19 shows an artificial stoma device 100 implanted within apatient's stomach with a line of gastroplasty sutures or staples 104 toreduce the gastric volume and a line of sutures or staples 304longitudinally dividing the small intestine to create a biliopancreaticchannel 308 separate from the intestinal lumen 310 with an optionalstent 306 to keep the bile/pancreatic channel 308 open and preventscollapse of the channel.

FIG. 20 shows a cross section of the patient's small intestine showingthe biliopancreatic channel 308 with an optional stent 306.

FIG. 21 shows a combined gastric 200 and intestinal 300 sleeve deviceimplanted within a patient's stomach with a gastric balloon 220 toreduce the gastric volume.

In summary, one aspect of the invention provides a method and system fortreatment of morbid obesity that has three components, an artificialstoma device, an internal gastric sleeve and an internal intestinalsleeve, which can be used separately or in combination. The artificialstoma device is implanted into a patient's stomach or lower esophagusand then can optionally be used to restrict food intake. The artificialstoma device may have a fixed aperture, an adjustable aperture or anaperture that varies in response to changing stomach conditions. Theartificial stoma device may be implanted using sutures, staples, areinforced anchoring segment, a sutureless or other attachment mechanismas described herein. A restriction can optionally be placed within thelumen of the gastric sleeve. The internal gastric sleeve may be separatefrom or integrated with the artificial stoma device. The internalgastric sleeve effectively reduces the patient's gastric volume andrestricts the absorption of nutrients and calories from the food thatpasses through the stomach. The internal intestinal sleeve may beseparate from or integrated with the internal gastric sleeve and/or theartificial stoma device. The wall of the internal gastric sleeve and/orinternal intestinal sleeve may be constructed with reinforcing rings ora spiral reinforcement. The wall of the internal gastric sleeve and/orinternal intestinal sleeve may have openings or valves to allow orrestrict the digestive secretions and nutrients through the wall of thesleeve. Along with these components, the treatment system may alsoinclude an attachment system that uses wire fasteners for performing agastrostomy and a stent for supporting a bile/pancreatic channel in thepatient's small intestine.

The method provided by this invention has the capacity to combine thesevarious components, as well as other components described herein, into asystem that treats obesity by creating a pouch with an outletrestriction which can be optionally controlled or operable, placingmeans by which the food exiting the pouch is transferred via gastric andintestinal sleeves to a point in the intestine while being substantiallyisolated from (or allowed to contact a controlled amount) gastric,biliary, pancreatic and intestinal secretions, whereby this location inthe intestine can be optionally selected to induce various reactions ofthe intestinal tissue which may include dumping syndrome, hormonalsecretion and/or nervous stimulation.

In contrast to previous devices, the present inventors have found thatin many cases an effective gastrointestinal sleeve device willpreferably have the characteristics of each section of the devicetailored to the function of the section of the gastrointestinal tract inwhich it resides. For example, in some clinical situations a potentialissue with gastric pouch or sleeve systems could be a lack ofphysiological signals causing opening of the pylorus. If the pyloruswere to remain tightly closed over a sleeve passing through, it could beproblematic for the patient. In these clinical situations, one desirablecharacteristic of an effective gastrointestinal sleeve device could befor it to have sufficient volume and/or compliance in the area of thestomach immediately upstream of the pylorus to create enough pressure orwall tension in that area to trigger the opening of the pylorus to emptythe stomach contents.

In addition, when normal functioning of the pylorus is clinicallydesired, the section of the sleeve device that passes through thepylorus must have enough wall flexibility or compliance to allow normalopening and closing of the pylorus and to allow drainage of stomachsecretions around the outside of the sleeve. For example blow molded 90A durometer polyurethane of a wall thickness on the order of 0.005″ orless will work in this manner. Other sections of the gastrointestinalsleeve device will also be tailored to the section of thegastrointestinal tract in which it resides.

The configuration of the gastrointestinal sleeve device enables a methodof treatment for morbid obesity that includes isolating ingested foodfrom the digestive secretions of the stomach and intestines as the foodpasses through the stomach, the duodenum and the upper part of thejejunum.

FIG. 22 illustrates an example of a gastrointestinal sleeve device 400constructed in accordance with the present invention. Thegastrointestinal sleeve device 400 is shown deployed within a patient'sgastrointestinal tract for treating morbid obesity. The characteristicsof each portion or section of the gastrointestinal sleeve device 400 maybe tailored to the function of the section of the gastrointestinal tractin which it resides.

The proximal opening 402 of the gastrointestinal sleeve device 400 isprimarily designed to facilitate attachment of the sleeve within thepatient's stomach. Depending on the clinical needs of the individualpatient and the judgement of the physician, locations for attachment ofthe proximal opening 402 of the sleeve may include the gastroesophagealjunction and the cardia or cardiofundal border. The gastroesophagealjunction is advantageous as a possible attachment site because thetissue wall is relatively thick at this location and it is relativelyeasy to access via a per oral route. Attachment at the gastroesophagealjunction excludes all gastric secretions from the interior of thegastrointestinal sleeve device 400. The cardiofundal border is alsoadvantageous as a possible attachment site because it provides theability to create a gastric pouch from the cardia of the stomach and thetissue wall is relatively thick at this location compared to the fundus.Attachment at the cardia or cardiofundal border allows the secretions ofthe cardia, which are primarily lubricious mucous, to enter the interiorof the gastrointestinal sleeve device 400 and excludes the fundalsecretions, which are high in acid content, from the interior of thesleeve. The lubricious mucous secretions from the cardia will help tolubricate the interior surface of the gastrointestinal sleeve device 400and will facilitate passage of ingested food through the sleeve.

By way of example, the embodiment of FIG. 22 shows the proximal opening402 of the gastrointestinal sleeve device 400 attached at thegastroesophageal junction. In this configuration, it can be preferredthat the proximal opening 402 be sized to have a diameter approximatelyequal to, or slightly larger than the diameter of the esophagus at thegastroesophageal junction. In adult humans, the esophagus at this pointtypically has a diameter of approximately 1.5-2.0 cm.

Attachment of the proximal opening 402 of the gastrointestinal sleevedevice 400 within the stomach can be accomplished using open,laparoscopic or endoscopic surgical techniques e.g. sutures, wires orstaples or using any of the attachment methods described herein.Attachment is preferably optimized to distribute stress over an enlargedarea and minimize stress or strain transmitted to the tissue where it isattached in order to minimize tissue erosion. During ingestion of food,the sleeve and the attachment must withstand the pressure created byswallowing as the food is forced into the sleeve. This is particularlytrue if there is a restriction downstream of the proximal sleeveopening. The sleeve and the attachment must also withstand any tensileforces created as a result of swallowing food and the presence of anyfood or liquid within the sleeve or pouch, as well as forces due toperistaltic action of the intestines or stomach.

In one embodiment shown in FIGS. 23A and 23B, the proximal opening 402of the gastrointestinal sleeve device 400 is attached to the stomachwall with an optionally removable, healable fixation system 430. Thefixation system 430 is configured with two components: an anchor ring422 and an attachment means 424 for connecting the gastrointestinalsleeve device 400 to the anchor ring 422. The attachment means 424 couldbe configured as part of the anchor ring 422 or the gastrointestinalsleeve device 400 or as one more separate components. The fixationsystem 430 is configured to operate in three different modes. It canprovide a permanent or long-term attachment of the gastrointestinalsleeve device 400 to the stomach wall; it can allow replacement orrevision of the gastrointestinal sleeve device 400 without removal ofthe anchor ring 422; and it can be removed completely to allow thestomach wall to heal where the anchor ring 422 had been attached.

The anchor ring 422, shown in FIG. 23A, may be configured as acontinuous wire, polymer or wire-reinforced polymer ring with anexterior or coating that resists ingrowth and adhesion. The wire couldbe NiTi or SS. Suitable polymers would include silicone, Teflon (PTFE)and other fluoropolymers. Possible coatings include hydrophiliccoatings, hydromers, hydrogels and fluoropolymers. Portions of theanchor ring 422 can be enclosed with a material 428 that encouragesingrowth of tissue. Between the portions of ingrowth material 428, theanchor ring 422 can be bare to discourage ingrowth and to provideattachment points for the gastrointestinal sleeve device 400. Theingrowth material 428 in this embodiment is preferably a biodegradableor resorbable material such as polyglecaprone (Monocryl, Ethicon),polyglactin (Vycril, Ethicon), or other known biodegradable orresorbable material. The ingrowth material 428 is configured so ingrowthresults in a partial and intermittent encapsulation of the anchor ring422. Areas of encapsulation would be interspaced with areas where ringwas exposed.

In one example of the fixation system 430 shown in FIG. 23A, theattachment means 424 is configured with a plurality of clip rings 426mounted around the exterior of the gastrointestinal sleeve device 400near the proximal opening 402. The clip rings 426 are configured withgaps in the rings that allow the rings to clip onto the exposed bareportions of the anchor ring 422 to hold the gastrointestinal sleevedevice 400 in position. In other embodiments, the attachment means 424may comprise magnets, clips, hooks, staples, sutures or other knownfasteners.

In one method, the anchor ring 422 would be implanted and allowed toheal before another device, such as the gastrointestinal sleeve device400, would be attached to it. After sufficient healing has taken place,the device could be attached to the anchor ring at areas where ingrowthdid not occur, as shown in FIG. 23B. In this method/structure abiodegradable ingrowth material is used and since the ingrowth materialis biodegradable, it will eventually disappear after providing ascaffold for ingrowth resulting in intermittent encapsulation of theanchor ring.

FIG. 23B also shows no restriction at the attachment stoma and norestriction in the sleeve thereby showing the pylorus acting as anaturally controlled restriction as described herein.

In another example of an alternate embodiment the sleeve of FIG. 23Bcould use an attachment ring and ring interface as shown in FIGS. 77-84which are attached to the stomach using T-tag fasteners or T-pledgets asdescribed herein.

The anchor ring and the gastrointestinal sleeve device 400 can be leftin place permanently. Alternatively, the gastrointestinal sleeve device400 can be removed at a later date and replaced or revised. If and whenit is desirable to remove the anchor ring, one or more or areas with noingrowth can be used as access to sever or cut the ring. Since the ringexterior resists ingrowth and is nonadherent, it can be pulled out ofthe tissue without damaging the tissue. After removal of the anchorring, the tunnel through the tissue formed by the encapsulation canheal.

As an alternative to a biodegradable material, a nondegradable scaffoldmaterial can be used. These materials become incorporated into tissueand are often made of naturally occurring or biological components, suchas processed bovine tissue.

FIG. 24A shows another way of attaching the proximal opening 402 of thegastrointestinal sleeve device 400 within the patient's stomach. Acombined attachment/stoma device 432 is implanted into the patient'sstomach to create a restriction and the gastrointestinal sleeve device400 is attached to the stoma device. The stoma device 432 and thegastrointestinal sleeve device 400 may be implanted in a singleprocedure or they may be implanted in two sequential procedures asdescribed above, leaving enough time for healing of the gastric wall inbetween the two procedures. The stoma device 432 may be attached at thegastroesophageal junction or it may be attached at the cardiofundalborder to create a reduced volume reservoir upstream of the restriction(gastric pouch) using the tissue of the cardia, as shown in FIG. 24A.The gastrointestinal sleeve device 400 may be attached using any one ofthe stoma devices described herein. By way of example, thegastrointestinal sleeve device 400 of FIG. 24A is shown attached using astoma device 432 in the form of a stomal ring clip.

In general, the proximal end of the gastrointestinal sleeve device 400may be secured in the vicinity of the lower esophageal sphincter orz-line, using a stoma device 432 having any of a variety ofconfigurations including those illustrated in FIGS. 24A-D. As usedherein, the term “stoma device” includes devices which define anopening, without limitation to the relative size of the opening comparedto the surrounding anatomy unless otherwise described.

Referring to FIGS. 24A and 24B, the stoma device 432 includes at leastone tissue contacting surface 420 for contacting tissue such asillustrated in FIG. 24A. The tissue contacting surface 420 may becarried by an anchor support 421 such as a transverse flange 422. In theillustrated embodiment, the transverse flange 422 comprises a continuousradially outwardly extending annular support. However, the anchorsupport 421 may comprise a plurality of radially outwardly extendingconnection tabs such as two or four or six or eight or more, which maybe circumferentially symmetrically positioned about the longitudinalaxis of the gastrointestinal sleeve 400. As is described elsewhereherein, the gastrointestinal sleeve 400 may be either permanently ordetachably connected to the anchor support 421. The anchor support 421may be provided with a plurality of apertures 427 such as to receive a“T” fastener or other tissue connector as is discussed elsewhere herein.Alternatively, the anchor support 421 may be pierceable by thedeployment of the “T” fastener or other tissue connector.

In a modification of the anchor support 421 (see FIG. 24C), the at leastone tissue contacting surface 420 faces radially outwardly from thelongitudinal axis of the gastrointestinal sleeve 400. In thisconfiguration, the “T” fastener or other tissue anchor may extendradially outwardly into adjacent tissue, as may be desirable dependingupon the tissue anchor configuration. The tissue contacting surface 420may also be inclined with respect to the longitudinal axis of thegastrointestinal sleeve 400.

Referring to FIG. 24D, at least a first tissue contacting surface 420 iscarried by a first anchor support 421 and at least a second tissuecontacting surface 423 is carried by at least a second anchor support424. In the illustrated embodiment, each of the first anchor support 421and second anchor support 424 is illustrated as an annular flange.However, the anchor supports may take any of a variety of configurationsas has been discussed. In addition, the first anchor support 421 andsecond anchor support 424 are spaced axially apart, to allow tissue 425to be drawn therebetween. Tissue 425 may be drawn between the first andsecond anchor supports using vacuum, supplied by the deploymentcatheter. This configuration enables the advance of a fixation device426 between the first anchor support 421, through the tissue 425 andinto or through the second anchor support 424 as illustrated in FIG.24D. The device shown in FIG. 24D can optionally be configured to enablefull thickness plication and serosa-to-serosa contact at the fixationdevice 426 as described herein. The fixation device 426 may comprise a“T” fastener, a pin, or other structures disclosed herein. In theannular construction illustrated in FIG. 24D, two or four or more tissueextensions 425 may be drawn radially inwardly, for attachment to thestoma device 432.

The attachment described in FIG. 24A can also be used where theattachment is dimensioned so as not to create a restriction. In thiscase, a restriction can optionally be placed downstream within thegastric sleeve. It is generally clinically preferable for devices placedat the gastroesophageal junction to have the stoma downstream, whiledevices placed at the cardiofundal border may combine the restrictionwith the attachment to allow a smaller food reservoir upstream of therestriction.

Downstream of the proximal opening 402, the gastrointestinal sleevedevice 400 has sleeve portions 404, 406 that reside in the fundus andthe antrum of the stomach, respectively. In the example of FIG. 22, thegastrointestinal sleeve device 400 has an approximately constantdiameter from the proximal opening 402 to the upstream end 408 of thepylorus, including the fundus portion 404 and the antrum portion 406 ofthe sleeve. In this embodiment, the sleeve through the fundus and antrumportions 404, 406 preferably has a diameter approximately equal to orslightly larger than the diameter of the esophagus at thegastroesophageal junction, which in adult humans is approximately1.5-2.0 cm. Alternatively, the gastrointestinal sleeve device 400 maygradually taper outward or open immediately downstream of the proximalopening 402, as shown in FIG. 24A. In this embodiment, thegastrointestinal sleeve device 400 preferably has a proximal opening 402with a diameter of approximately 1.0-1.5 cm where it is attached to thestoma device 432. Downstream of the proximal opening 402, the fundus andantrum portions 404, 406 of the sleeve have a diameter of approximately1.5-2.0 cm.

The example illustrated in FIG. 24A may utilize any of a variety ofdimensions, materials, attachment structures and other featuresdisclosed elsewhere herein. In general, the example of FIG. 24A isprovided with a substantially uniform inside diameter throughout itsaxial length. Axial lengths between the proximal opening 402 and adistal end of the device are generally in excess of 50 cm, often atleast about 75 cm to 125 cm or more, depending upon the desired clinicalperformance as has been described elsewhere herein. In oneimplementation of the invention, the tubular wall of thegastrointestinal sleeve 400 is sufficiently flexible that the naturaloperation of the pylorus operates as an adjustable stoma on materialtraveling through the sleeve 400.

The sleeve 400 may be attached in the vicinity of the gastroesophagealjunction, such as by attachment to a ring or cuff or directly attachedto the cardia of the stomach adjacent the gastroesophageal junction.Attachment may be accomplished in any of a variety of ways includingthose disclosed elsewhere herein, such as “T” fasteners including T tagssuch as illustrated in FIG. 91A or T pledgets such as illustrated inFIG. 91B. Such anchors may be positioned utilizing the placementtechniques illustrated, for example, in FIG. 94A through 94C.

The sleeve 400 may comprise a homogenous material throughout. At leastthe gastric section may comprise a sufficient length to extend throughthe gastroesophageal junction, past the pylorus and into the duodenum.Materials such as a blow molded polyurethane, having a wall thickness ofapproximately 0.005″ and a durometer of about 90 A may be used. Thesleeve 400 may additionally be provided with a lubricious coating on oneor more of the interior and exterior surfaces. Diameters on the order ofabout 2.0 cm, ±50% or more may be utilized. Other dimensions andmaterials may be optimized by those of skill in the art in view of thedisclosure herein.

The intestinal section of the sleeve 400 is dimensioned to start in theduodenum and extend at least about 50, often about 75 or 100 cm or more,to imitate a gastric bypass. The intestinal section of the sleeve 400may be the same diameter as the gastric portion of the sleeve, or may beno more than about 90% or 80% or less of the diameter of the gastricsleeve portion. Delivery and retrieval techniques for the implementationof the invention illustrated in FIG. 24A have been disclosed elsewhereherein.

The function of the sleeve portion 404 located in the zone of the fundusis to transmit food through the gastrointestinal sleeve device 400.Accordingly, this portion of the gastrointestinal sleeve device 400 maybe configured to resist kinking and provide a lubricious inner surface.Saliva and mucous secreted in the esophagus and/or cardia couldfacilitate passage of food. The zone of the fundus and/or the area ofthe cardiofundal border could be a possible location for a restrictionif one is used. Location of the restriction is clinically relevant inthat the volume between the restriction and the gastroesophagealjunction effectively defines a restricted stomach volume.

The antrum of the stomach has muscular action to grind food and thismuscular action can manifest as peristalsis. Based upon clinicalrequirements, the sleeve portion 406 in the antral zone could includestiffening members 410 or other means to prevent motion and/or kinkingof the sleeve. The stiffening members 410, which may be made of a metaland/or polymer, may be oriented axially, as shown in FIG. 22, or theymay be in a helical configuration or other geometry. This reinforcingshould be configured so as to provide little or no interface forperistaltic motion to capture the sleeve and move it toward the pylorus.The sleeve should also be configured to resist or avoid forces thatcould be applied in a retrograde direction. Note that the retrogradeforce is caused by fluid flow. As the antrum undergoes peristalsis, foodand secretions can flow retrograde. A slippery hydrophilic or othercoating, as described herein, on the exterior of the sleeve in theantrum portion 406 may be preferred.

In an alternate construction illustrated in FIG. 25, the fundus portion404 and/or the antrum portion 406 of the gastrointestinal sleeve device400 may be stiffened using a coaxial inflatable balloon 440 thatsurrounds the sleeve. The coaxial balloon 440 may be inflated within thepatient's stomach using a detachable tether and a self-sealing valve asdescribed in the prior art (e.g. Pevsner). With proper selection ofinflation media (compressible air or incompressible liquid) inflationpressure and inner and outer wall compliance, the coaxial balloon 440can optionally provide axial stiffening, and can optionally serve totransmit peristaltic motion to the interior of the gastrointestinalsleeve device 400 to help ingested food transit through the sleeve.

Downstream of the antrum portion 406, the gastrointestinal sleeve device400 may optionally include a pyloric anchor 414 at the upstream end 408of the pylorus, as shown in FIG. 22. In one embodiment, the pyloricanchor 414 is configured as a perforated collar slidable along theexterior of the sleeve for custom fit to the patient. The outercircumference of the pyloric anchor 414 is optionally attached to thestomach lining at the upstream end 408 of the pylorus, then the slidablecollar is cinched around or otherwise attached to the sleeve to anchorit in position. Perforations or channels in the collar allow gastricsecretions to pass from the stomach into the pylorus withoutobstruction. The pyloric anchor 414 can be constructed from a variety ofbiocompatible materials with different properties. For example,fluoropolymers such as Teflon (Dupont) can be used to avoid ingrowth or,alternatively, polyester cuff materials (e.g. Dupont Dacron) can be usedto encourage ingrowth if desired. As an alternative to attaching thepyloric anchor top the stomach wall, it can be constructed withsufficient stiffness and sized to be retained in the antrum of thestomach by being too large to pass through the pylorus.

An anchor placed in the antrum can also be used as a platform to supportdevices placed in the stomach. For example, combining such an anchorlocated in the antrum with the reinforced sleeve or coaxial balloon asdescribed herein can be used to support an attachment ring and reducethe forces transmitted to the attachment at the stomach wall. Structuresthat are not a part of the gastric sleeve such as self-expanding wiremeshes of NiTi or stainless steel could also be used where clinicallyindicated. Antral support structures could also be independent, as asleeve anchor and could optionally be used to support other devices asdescribed herein.

In certain embodiments, the sleeve is configured to open and to collapseas it passes through the pylorus to facilitate internal passage of foodand external passage of gastric secretions and to minimize irritationand/or damage to the pylorus. Additionally, the gastrointestinal sleevedevice 400 may optionally narrow slightly in diameter as it passesthrough the pylorus so that it facilitates passage of gastric secretionsalong the exterior of the sleeve through the pylorus when it is opened.This diameter may be on the order of 0.75-2.5 cm. The pylorus section412 of the gastrointestinal sleeve device 400 must have enough wallflexibility or compliance to allow normal opening and closing of thepylorus and to avoid irritation of the pylorus. For example blow molded90 A durometer polyurethane of a wall thickness on the order of 0.005″or less will work in this manner. With this configuration one canoptionally use the pylorus as a natural stoma by allowing the sleeve tobe closed by the pylorus and then opened to allow passage of food whenthe muscles of the pylorus relax.

Conversely, in some patients it may be desirable to hold open thepylorus. In such cases where the device is configured for holding openthe pylorus, it should also include means of draining gastricsecretions, e.g. tubes or channels, along the exterior of the sleeve.

A collapsible or collapsed tubular gastrointestinal sleeve device canallow gastric and intestinal secretions to pass along its outer surface.Spiral reinforcing can facilitate passage of the secretions if thesleeve between the reinforcing is configured to form channels wheresecretions can flow between the reinforced sleeve and the wall of theintestine or pylorus with which it may be in contact. This could be ofparticular use in the pylorus where food in the sleeve could becompeting with gastric secretions to pass through the pylorus outsidethe sleeve. In the case of a flaccid sleeve, whichever of the food orsecretions has the higher pressure would pass through the pylorus. Inthe case of a spiral reinforced sleeve with channels or other means(e.g. tubular lumens passing through the pylorus and with openings bothproximal and distal to the pylorus) of enabling passage of secretionsalong the pylorus, the food and secretions could pass at the same time.

The gastrointestinal sleeve device 400 continues below the pylorus andpasses through the duodenum and into the jejunum. The duodenum portion416 and the jejunum portion 418 may have a total length of approximately50-200 cm, depending on the clinical needs of the individual patient andthe judgement of the physician. Shorter lengths may be used if it isdesirable for the sleeve to empty into the duodenum or proximal jejunum.Longer lengths can be used if it is desirable to have the sleeve emptyin the distal jejunum or ileum. In certain embodiments, the sleeve 400may be configured with a length of 100 cm as this is a standard lengthof the roux limb in a Roux-en-Y gastric bypass. A sleeve 400 with alength of approximately 500 cm or more can be used to perform anonsurgical biliopancreatic diversion for achieving results similar to aScopinaro procedure. In one configuration, the gastrointestinal sleevedevice 400 has an approximately constant diameter of approximately0.75-2.5 cm through the duodenum portion 416 and the jejunum portion418. This diameter is less than the internal diameter of the smallintestine through these sections to allow free flow of gastric, biliary,pancreatic and intestinal secretions along the outside of the sleeve.This diameter can be optimized for individual patients where a smallerdiameter may be tolerated better and a larger diameter may be superiorregarding the passage of food. Collapsibility may allow use of largerdiameter sleeves, while sleeves of smaller diameter and greaterresilience may be clinically indicated to minimize irritation.

Past the pylorus and past the duodenum, the gastrointestinal sleevedevice 400 may include means to couple peristaltic muscular action ofthe intestine and use it to apply antegrade tension to the sleeve. Oneor more rings 420 in the sleeve may provide this coupling. The rings 420may include a metallic spring to return the ring to its circular shapeif collapsed by either the installation procedure or by peristalticaction of the intestine. The rings 420 may be positioned in the jejunum,as the duodenum exhibits little or no peristalsis. Alternatively, theexterior of the sleeve may be configured with small bumps or otherfeatures to provide a small amount of friction for coupling with theperistaltic muscular action of the intestine. A balance can be struckbetween friction and lubricity on the exterior of the sleeve. Thereshould be enough friction so that peristalsis will act to straighten thesleeve and apply a small amount of tension to keep it in place. Too muchfriction, however, will allow the intestinal wall to “climb” up theexterior of the sleeve due to peristalsis, which would generally not bedesirable. For example, this balance can be achieved using a smoothpolyurethane sleeve with PHOTOLINK LUBRICIOUS COATING (Surmodics Inc.)or other**. However, in some clinical situations it may be desirable toachieve this end result. This can be achieved by using rings or othermeans of mechanically coupling the sleeve with the intestinalperistaltic action. In this case the intestine essentially crawls up thesleeve and takes on a pleated bellows like configuration. This can havethe result of effectively lengthening the sleeve, as food would now exitthe sleeve at a more distal location within the intestine.

It may be desirable in some clinical circumstances to provide atemporary peristalsis coupling that can straighten the sleeve for aperiod of time after insertion and not couple with the peristalticaction after this period. This will tend to reduce the climbing of theintestine and can allow any previous change in the position of theintestine to return to normal. This can be accomplished by using abiodegradable coupling means such as a dissolvable peristalsis ring or ahigh friction coating that comes off, leaving a lubricious surface. Aballoon that detaches or deflates could be another means ofaccomplishing this end. For example, the balloons and other features inFIGS. 32A, 32B and 32C can be configured for this application. Suchballoons can be made self-deflating by the inclusion of a dissolvableportion or by inflation with a hypo-osmolar fluid combined with use ofosmotically active balloon membrane. In this event the inflation fluidwill escape the balloon through the membrane due to the osmoticimbalance between the inflation fluid and the contents of the intestine.

Optionally, the gastrointestinal sleeve device 400, along some or all ofits length, may be configured by means of controlled wall thickness orreinforcing so that, if the sleeve is folded or kinked, open channels442 will be maintained, as shown in FIGS. 26A, 26B and 26C. In this caselocally increased wall rigidity may also be used to control the foldpreferences of the sleeve.

Alternatively, the gastrointestinal sleeve device 400, along some or allof its length, may include axial channels 444, as shown in FIGS. 27A and27B. The axial channels would be configured so that, in the event of afold or kink in the sleeve, the lumen of the sleeve remains patent andopen. These channels can also be formed by peaks and valleys in aconstant thickness sleeve wall in addition to the manner diagrammed.

In one embodiment of the gastrointestinal sleeve device 400, the gastricand intestinal portions of the sleeve are constructed to be normallycollapsed to a somewhat flattened configuration when in a rest position,such as is shown in FIG. 26B, 26C or 27B. This can minimize thepotential for irritation of the mucosa in the stomach, the pylorus andthe intestine and other structures such as the ampula of Veder. Thesleeve may open or expand to a circular cross section, as shown in FIG.26A or 27A, for the passage of ingested food. Thus the stomach andintestinal walls would not be constantly subjected to stimulation, whichcould result in increased secretion and/or peristaltic action.Alternatively, some or all of the gastric and intestinal portions of thesleeve may be constructed to remain in an open or expanded configurationwhen in a rest position and to easily collapse when subjected toexternal pressure, for example to allow passage of digestive secretionsalong the exterior or the sleeve. This second option may also includediametric sizing based upon the clinical desirability of stimulating thepassage wall (similar diameter to passage) or not (smaller diameter thanpassage).

The gastrointestinal sleeve device 400 is generally impermeable alongits entire length to isolate ingested food from digestive secretions.However, it may be desirable to have the gastrointestinal sleeve device400 having semipermeable or controlled permeability properties alongsome or all of its length to allow absorption of certain nutrients atthe appropriate location in the stomach or intestine in order to avoidmalabsorption complications while still limiting caloric absorption. Forexample, in the duodenal portion it would be beneficial to allow Ironand B-12 to exit the sleeve so that it can be absorbed through theintestinal wall.

FIG. 28 illustrates an optional one-way valve 450 feature of thegastrointestinal sleeve device. Positioning of valves may be patientdependent. One clinically significant location could be at or near thetransition from the duodenum, where there is little or no peristalticaction and the jejunum where peristalsis occurs. Other significantlocations include the distal opening of the device (to prevent flow intothe sleeve), the proximal opening of the device (to prevent reflux intothe esophagus) and at or near the pylorus (to help ingested food passthrough the pylorus and duodenum). A valve upstream of a restriction mayalso help, in combination with contractions or peristalsis of thestomach, to force ingested food through the restriction.

FIG. 29 illustrates another example of a gastrointestinal sleeve device400 deployed within a patient's gastrointestinal tract for treatingmorbid obesity. In this embodiment, the proximal opening 402 of thegastrointestinal sleeve device 400 has a flared opening that isconfigured for attachment at the cardiofundal border. Attachment at thecardiofundal border confers different advantages to the gastrointestinalsleeve device 400, as described above. Attachment can be made using anyof the methods described herein. The proximal opening 402 has a diameterof approximately 2-10 cm, which smoothly tapers down to a diameter ofapproximately 1.5-4.0 cm through the fundus portion 404 and the antrumportion 406 of the sleeve. The remainder of the gastrointestinal sleevedevice 400 may be configured similarly to the embodiment described inconnection with FIG. 22.

FIG. 30 illustrates another example of a gastrointestinal sleeve device400 having a reservoir 452 located above the patient's pyloricsphincter. The reservoir 452 allows ingested food to accumulate in theantrum of the stomach and to apply pressure against the pylorus, whichmay contribute to periodic opening of the pyloric sphincter for properemptying of the stomach contents. Alternatively or in addition, areservoir 452 may be positioned elsewhere in the gastrointestinalsystem, for example just below the GEJ, to provide a sensation offullness and satiety. FIG. 30 also illustrates the optional feature of arestriction 454 in the gastrointestinal sleeve device 400 between theproximal opening 402 and the upstream end 408 of the pylorus. Therestriction 454 can be provided by a simple narrowing of the sleeve 400or, as illustrated in this embodiment, can be provided by a stoma device454 positioned within the lumen of the sleeve 400. The stoma device 454can be an adjustable stoma device, a smart stoma or any of the stomadevices described herein. Positioning of the stoma device relative tothe proximal sleeve opening can be selected as clinically indicated toprovide a reservoir for food proximal to a restriction** that isappropriate for the desired weight loss. In other embodiments of thegastrointestinal sleeve device 400, sufficient reduced volume orresistance to ingestion of food for encouraging weight loss may beprovided by the length and diameter of the gastric portion of the sleeve400 without the need for a stoma device or other restriction other thanthe use of the pylorus as a natural restriction as described above.

When the pylorus is used as a natural stoma to control food flow, anelectrical stimulation system can optionally be used to control theopening and closing of the pylorus. This system could include one ormore electrodes for stimulating the pylorus, a stimulator (includingpower source and controlling electronics) and one or more optionalsensing electrodes.

FIG. 31 illustrates another example of a gastrointestinal sleeve device400 having an inflatable gastric balloon 460 to enhance satiation bytaking up volume in the stomach. The gastric balloon 460 may be arrangedcoaxially around the sleeve or it may be configured to inflatepreferentially toward the greater curvature of the stomach, as shown inFIG. 31. The gastric balloon 460 may be inflated within the patient'sstomach using a detachable tether and a self-sealing valve.Alternatively, the gastric balloon 460 may be made self-inflating byhaving a hyperosmolar material within the gastric balloon 460 and anosmotically active balloon membrane (complete or partial). The gastricballoon 460 can be configured to transmit peristaltic motion to theinterior of the gastrointestinal sleeve device 400 to help ingested foodtransit through the sleeve as described above. Optionally, the sleeveunder and around the gastric balloon 460 may be combined with one ormore one-way valves 450 positioned upstream and/or downstream of thegastric balloon to assist peristaltic action to urge ingested foodthrough the sleeve.

FIGS. 32A, 32B, 32C and 32D illustrate optional features to assist inthe deployment of the gastrointestinal sleeve device within a patient'sgastrointestinal tract. FIG. 32A illustrates a gastrointestinal sleevedevice 400 having an inflatable balloon 462 on its distal end. Theballoon 462 is inflated via an inflation lumen 464 that extends throughthe gastrointestinal sleeve device 400. The inflation lumen 464 can beincorporated into the wall of sleeve 400 or it can be in a coaxialtubular tether that can be separated from the sleeve 400 to deflate theballoon 462 once the sleeve is fully deployed within the patient'sintestine. The balloon 462 is inflated after the distal end of thesleeve 400 is past the pylorus and the inflated balloon is carrieddistally by peristaltic action of the intestines. Once the sleeve isfully deployed within the patient's intestine, the balloon 462 can bedeflated. The balloon can alternately be inflated prior to insertioninto the body, thereby not requiring an inflation lumen the length ofthe device, and can either deflate naturally or have an active means ofdeflation as described herein. In an alternate embodiment the means toattach the balloon to the distal sleeve would be biodegradable and afterthe degradation of the attachment means the balloon would pass throughthe digestive tract naturally.

FIG. 32B illustrates a gastrointestinal sleeve device 400 having asponge or foam member 466 on its distal end. The use of a foam member466 simplifies the gastrointestinal sleeve device 400 in that aninflation lumen is unnecessary to expand the foam member 466. The foammember 466 is allowed to expand after the distal end of the sleeve 400is past the pylorus and the expanded foam member 466 is carried distallyby peristaltic action of the intestines. The foam member 466 can bebiodegradably attached, as described above, or made of a dissolvable ordigestible material so that it disappears after it has served itspurpose.

FIG. 32C illustrates a variation of the gastrointestinal sleeve device400 of FIG. 32A, wherein the inflatable balloon 462 is mounted on aflexible tail 468 formed on or attached to the distal end of the sleeve.

FIG. 32D illustrates a variation of the gastrointestinal sleeve device400 of FIG. 32C, wherein the inflatable balloon is replaced with amagnet 470. This magnet 470 can be used in conjunction with othermagnets, to guide the deployment of the intestinal sleeve. Matchingguide magnets of opposing polarity can be used internal to the intestinein conjunction with an endoscope, within the abdomen external to theintestine in conjunction with a laparoscope or external to the body in amanner similar to that described by Gabriel in U.S. Pat. No. 5,431,640.In an alternate embodiment the means to attach the magnet to the distalsleeve would be biodegradable and after the degradation of theattachment the magnet would pass through the digestive tract naturally.

In summary, the present invention provides a gastrointestinal sleevedevice which allows separation of ingested foods and liquids fromdigestive secretions through the stomach and past the duodenum andoptionally into the jejunum or ileum. This is of particular significancebecause gastric acids are neutralized by bile and duodenal secretions.This prevents digestion from gastric acid taking place even if the foodand gastric secretions are allowed to mix at a later point in theintestines.

FIG. 33 shows a cutaway view of a portion of a human digestive system,with an embodiment of the biliopancreatic diverter tube 500 in situ. Thebiliopancreatic diverter tube is comprised of a tube that diverts bilesalts released from the gallbladder 508 and pancreatic juices from thepancreas (shown with dotted lines) from being discharged into theduodenum at the duodenal papilla 512, and instead allows for dischargeof these fluids farther downstream within the small intestine 510 fromthe distal tip 502 of the device.

The proximal end of the embodiment of FIG. 33 is bifurcated, so that theproximal end of the device has two branches, a bile duct branch 504 thatextends into the common bile duct 514, and a pancreatic duct branch 506that extends into the pancreatic duct 516.

FIG. 34 shows an alternative embodiment of the biliopancreatic divertertube 520 where the proximal end is not bifurcated. Instead, the proximaltip 524 extends into the common bile duct as shown, and the proximal endhas an array of inlet ports 526, or a single larger inlet port, forcollecting pancreatic juices from the pancreatic duct. The pancreaticjuices and bile salts collected at the proximal tip 524 and the array ofinlet ports 526 flow through a common lumen connecting to the distal tip522 of the diverter tube 520. The pancreatic juices and bile salts areprevented from avoiding the diverter tube by an annular stop member 528that forms a seal between the device 520 and the surrounding duct.Alternatively, the tube may be sized for a tight fit in the duct,obviating the need for the annular stop member.

In addition to the two embodiments shown, other configurations may benecessitated by anatomical variations.

In an alternative embodiment, the device 520 could have a dual lumenaligned coaxially, so that an inner lumen would collect bile salts fromthe proximal tip 524, perhaps tapered so that only the inner lumen'sproximal orifice is exposed at the proximal tip, and the outer lumenwould collect pancreatic juices from the array of inlet ports 526 orsingle inlet port. Alternatively, the device 520 could have a dual lumenaligned side-by-side, or in some other arrangement.

Alternatively, the proximal tip 524 of the device could be placed withinthe pancreatic duct, and the array of inlet ports 526 or single inletport would collect bile salts.

The portion of the device in the intestine may be semipermeable,allowing certain materials from the intestine to pass into the tube,such as acids. Alternatively, the portion of the device in the intestinemay only allow certain materials from inside the device to permeate out,such as bases to neutralize stomach acids. It should be noted that theduodenum also excretes bases to neutralize stomach acids.

The lumen of the diverter tube is preferably of a diameter to allow flowof bile and pancreatic secretions the tube. Optionally, the divertertube may be constructed with flexible walls to allow peristaltic motionsof the intestinal wall to effect movement of bile and pancreatic juicesthrough the diverter tube.

The interior and/or exterior of the diverter tube can optionally beformed from a relatively inert material such as a polyolefin (e.g.polyethelene) or a fluoropolyment (e.g FEP or PFA) or coated with a lowfriction material (e.g. a hydrogel) to reduce friction of bile andpancreatic juices (interior) and reduce native luminal irritation(exterior).

The interior of the diverter tube can optionally include a coating toresist crystallizing and/or deposition of bile and pancreatic secretionswhich could obstruct flow through the tube.

The wall of the diverter tube may be reinforced with rings or a spiralmade of wire and/or plastic. Optionally the diverter tube can includemeans for stabilization at the distal end such as a brush (as describedby Berry, U.S. Pat. No. 5,306,300), weight, or inflatable balloon.

FIG. 35 shows an embodiment of the biliopancreatic diverter tube 530being delivered using a transesophageal approach under visualizationwith a flexible endoscope 532. The endoscope 532 is passed through apatient's mouth, down the esophagus, into the stomach 534, past thepyloric sphincter 536, and into the duodenum 544. The distal end 538 ofthe endoscope is positioned adjacent to the duodenal papilla. Aguidewire is then passed through the endoscope and out of its distal end538, into the opening of the biliopancreatic duct at the duodenalpapilla, and advanced within the duct or ducts where an embodiment ofthe biliopancreatic diverter tube will eventually be positioned. Anembodiment of the biliopancreatic diverter tube 540 is then passed overthe guidewire. The guidewire is then removed.

Optionally, laparoscopic or open surgical techniques may be used toassist in or complete the implantation of the device.

The proximal end of the device may be anchored in place with a varietyof means. One means of anchoring the device is with an annular stopmember 542, as shown, that may be inflated to make contact with thesurrounding walls of the duct. Other means for anchoring an embodimentof the biliopancreatic diverter tube include integrating aself-expanding stent-type anchor on the proximal end of the device. Sucha stent may be coated with a dissolving material to delay expansion ofthe stent portion of the device until it is properly seated.Alternatively, a balloon expandable stent-type anchor may be used, orthe proximal end of the device may be barbed or toggled, or the tubeitself could be self-expanding, or the proximal end may be formed with apigtail curve, or the proximal end could be manufactured of a materialthat swells up with moisture, for example a hydrogel, hydromer or othermaterials as described herein. In addition, the outer surface of theproximal end of the device may be covered with a fabric to facilitateingrowth of tissue to secure the device in place. Some of theseattachment means will require the proximal tip of the device to beplaced in the gallbladder while others will attach within the bile duct.Stent-type anchors can also be configured for use as inlet ports toallow entry of pancreatic secretions into the tube.

Once anchored in place, the distal end of the device may be deployedfrom the endoscope. The endoscope could be pushed downstream within thesmall intestine as an embodiment of the biliopancreatic diverter tube ispushed out of the distal end of the endoscope. Alternatively, theendoscope could remain stationary, or even be retracted as an embodimentof the biliopancreatic diverter tube is pushed out the distal end of theendoscope, allowing peristalsis to then carry the distal end of thedevice downstream.

Typically, the device will be 50-510 cm in length and have an innerdiameter of 1.0-7.5 mm. The device could be made from a silicone,polyurethane, polyethylene or a fluoropolymer such as PFA. Devicecoatings could include hydrogels such as PVP (polyvinylpyrolidone orother coating such as parylene as described herein. Stent-type retentioncomponents could be stainless steel or NiTi.

Preferably, the diverter tube is constructed with radiopaque and/orsonoreflective materials and/or includes one or more radiopaque and/orsonoreflective markers for enhanced imaging by X-ray, fluoroscopy and/orultrasonic imaging so that the position and functional state of theimplanted intestinal sleeve can be verified noninvasively.

The biliopancreatic diverter tube 500 is an alternative to dividingintestine as described in FIGS. 17-20. It should be noted that thebiliopancreatic diverter tube does not isolate ingested food from thegastric juices, but neutralization of acid and action of biliopancreaticsecretions is delayed.

The biliopancreatic diverter tube is intended for use in conjunctionwith other surgical and/or interventional procedures for a combinedtreatment, for example using any of the devices and methods fortreatment of morbid obesity described herein.

In one aspect, the invention describes a number of fastener systems thatcan be used in situations where it is desirable to replace a portion ofthe fastening system, and any device or devices held in place by thefastener, while other portions of the system remain in place.

In particular, these systems are useful in attaching devices to theinside of hollow organs such as the stomach. Though these fasteningsystems generally consist of two or three components at each attachmentpoint, various components can be combined or connected. Some of thefastener systems can be applied to attachment ring systems and stomalring clip systems as described herein.

FIG. 36 illustrates a fastener system 600 with several fastener segments602, each segment having gripping fingers for attachment of a surgicalappliance. As shown in FIG. 36, six individual segments 602 arepositioned within a passageway of the body along a plane that liesapproximately perpendicular to the passageway, such that collectivelythey form an annular mounting surface along the perimeter of thepassageway with grasping fingers 604 extending away from the perimeterof the passageway, for attachment with another device. The fastenerssegments 602 and the grasping fingers 604 are preferably constructed ofa biocompatible metal or polymer or a composite or combination thereof.Suitable materials include, but are not limited to, stainless steel,titanium, NiTi alloys, cobalt alloys such as Elgiloy or MP35, elastomerssuch as silicone or polyurethane and other rigid or flexible plastics.In some embodiments, it may be desirable to construct a part or all ofthe fastener of a biodegradable or bioresorbable material. In certainapplications, it may be advantageous to have individual fastenersegments rather that one integrated device as shown in FIG. 38. Thatdecision may be informed by the following characteristic, the fastenersegments of FIG. 36 may be more flexible than the device of FIG. 38because they can move more independently of one another, and thus do nottransmit forces to one another.

FIG. 37 illustrates a sleeve member 606 that has been attached to theannular mounting surface created by the fastener system 600. When usedwithin the stomach, the sleeve member 606 and related components andfeatures function as a conduit for food within the gastrointestinaltract that essentially restricts the flow of food downstream with anarrow opening. These devices encourage weight loss by limiting the rateat which food can be consumed, and by contributing to the feeling ofbeing full, or satiated and other mechanisms. It should be noted thatalthough the sleeve member restricts the flow of food, the flow of foodis not substantially inhibited by the fastener segments. The fastenersegments 602 do remain attached to the perimeter of the passageway, andonly slightly protrude into the passageway. In addition, the fastenersegments 602 do not rely on folded tissue for anchoring purposes, andthis allows the inner diameter of the passageway to retain its originaldiameter. In some situations it is clinically preferable that thisdiameter is the same as the resting diameter of the hollow organ so asto transmit minimal force and result in little or no deformation of thewall from its resting position.

An example of a method of use that may be used with any embodiment ofthe fastener system of the present invention as described herein, thefastener or fasteners may be implanted into the stomach or anotherhollow organ and allowed to heal for a period of days or weeks. Aftersufficient healing time, a surgical appliance, such as agastrointestinal sleeve device, may be installed by attaching it to thefastener system. Alternatively, the surgical appliance may be installedat the same time as the implantation of the fasteners. In anotherexemplary method, a first surgical appliance, such as a gastrointestinalsleeve device, may be initially installed (either immediately or after aperiod of healing as described above.) Subsequently, the first surgicalappliance may be removed and, if desired, replaced with a secondsurgical appliance. For example, a first gastrointestinal sleeve devicewith an initial stoma size may be replaced with a secondgastrointestinal sleeve device with a larger or smaller stoma size. Thiscould be used to modify the treatment regimen as the patient graduallybecomes accustomed to consuming less food or it may be used to modify atreatment regiment to obtain better effective weight loss.Alternatively, gastrointestinal sleeve devices with incrementally largerrestrictive stoma sizes may be installed at the end of a successfultreatment regimen to wean the patient back to normal dietary guidelinesfor maintaining the weight loss.

The fastener system of the present invention may also be used forattachment and subsequent removal or replacement of a valve orrestriction at the gastroesophageal junction for treatment ofgastroesophageal reflux disease. In the alternative, the fastener systemmay be used in other hollow organs for attachment and subsequent removalor replacement of other surgical appliances, as described above.

Although FIG. 36 shows six individual fastener segments 602, it shouldbe noted that as few as two segments could be used, more than six couldbe used, and that between four and six segments can be preferred. Eachsegment 602 is shown having three gripping fingers 604, each orientedapproximately perpendicular to the surface of the passageway, with twoopposed relative to the third so that another device can be snappedbetween opposing fingers. The fingers 604 are flexible, yet rigid enoughto hold a device 606 in place, such as shown in FIG. 37, while alsoallowing that device to be removed at some later time, perhaps to bereplaced by another device.

The individual fastener segments 602 of FIG. 36 can be attached to thebody passageway in several ways. As shown, each segment 602 can beattached with sutures that pass through holes 608 positioned in eachcorner of each fastener segment. Alternative to sutures, wire, a staple,rivet or other type of fastener may be passed through each hole. Inaddition, the surface of each segment adjacent to the body's tissues maybe coated with tissue growth promoting materials, such as Dacron felt ormesh, to improve the attachment of the device to the body. Tissue growthpromoting materials may be used in conjunction with all embodimentsherein to improve attachment. The embodiment shown in FIG. 36 ispreferably configured so that its installation does not narrow thepassageway of the organ.

One skilled in the art can envision a corresponding insertion tool,which will temporarily deform the annular ring 610 or other attachmentsurface of the device 606 to allow facilitated passage of the device 606over the grasping fingers 604 of FIG. 36. One can also imagine that bycutting the annular ring 610 of the depending device 606 it could easilybe removed.

FIG. 38 shows an alternative embodiment of a fastener system 612comprising an annular shaped member 614 having gripping fingers 616 forattachment of a surgical appliance 606 within a hollow organ in apatient's body. The annular member 614 and the grasping fingers 616 arepreferably constructed of a biocompatible metal or polymer or acomposite or combination thereof. Suitable materials include, but arenot limited to, stainless steel, titanium, NiTi alloys, cobalt alloyssuch as Elgiloy or MP35, elastomers such as silicone or polyurethane andother rigid or flexible plastics (e.g. polyolefins or fluoropolymers).In some embodiments, it may be desirable to construct a part or all ofthe fastener of a biodegradable or bioresorbable material. The fastenershown here may be configured as a single component, and this featuremeans that it is more rigid within the body compared to an embodimentcomprising two or more fastener segments. This feature may be desirablein certain applications, such as for use within the circulatory system.However, when the device has portions made of a highly flexiblematerial, such as a low durometer silicone material, it can be madestretchable or deformable so that it can move with motion of the wall ofthe passageway, yet still maintain a grasp on any attached device withits fingers which are preferably made from a less elastic or rigidmaterial such as a higher durometer silicone, a rigid plastic or metalsuch as stainless steel or titanium.

In an alternative embodiment, the fastener system shown in FIG. 38 maybe designed so that it is essentially the fastener system of FIG. 36held together by bioresorbable material as polyglecaprone (Monocryl,Ethicon), polygalactyn (Vycril, Ethicon) or other known in the art, thusfacilitating installation. In this configuration, the one piece deviceof FIG. 38 could be installed relatively easily compared to themulti-piece device shown in FIG. 36, and also enjoy the flexibility ofthe device of FIG. 36 once the bioresorbable material has dissipated.

The embodiment shown in FIG. 38 is preferably configured so that itsinstallation does not narrow the passageway of the organ. The annulardimension is sized so that when the device is attached to the holloworgan it essentially fits into the organ with little or no stress on theorgan walls. The passageway of the organ substantially retains itsoriginal diameter.

FIG. 39 shows the fastener system 612 of FIG. 38 with a surgicalappliance 606 attached. The means of attachment shown in FIG. 39 withthe use of fingers 616 is just one of many possible means of attachment.For example, the device of FIG. 38 could be reconfigured so that it canaccommodate a bayonet mount (a fitting engaged by being pushed into asocket and twisted), wherein the sleeve member could be pushed into asocket formed by the annular shaped member and then twisted. Also, aninterference type of fit could be used wherein the sleeve member, forexample, could be attached to the annular member by simply resting overthe annular member because the sleeve member has a larger inner diameterat its proximal opening than the inner diameter of the annular member.The fitting may not alter the original diameter of the passageway. Theengagement means would be configured to secure the depending device toan attachment device that could be flexible, deformable and with avariable opening diameter. In addition to these types of attachmentmeans, magnets and barbs may also be employed.

FIG. 40A shows an alternative fastener system 618 comprising an annularshaped member 620 wherein the surface of the annular shaped memberalternates between having tissue growth promoting materials 619 such asDacron felt or mesh, and non-tissue growth promoting materials 621 suchas a fluoropolymer. The tissue growth promoting materials 619 areillustrated as having a rough surface, and are intended to becomeassimilated with the adjacent body tissue to supplement other attachmentmeans such as sutures, staples, clips or other means known in the art.The surface 621 of the annular shaped member that lacks tissue growthpromoting materials may be used for attaching another appliance ordevice. FIG. 40A illustrates this surface as having a hole or void 617that can be used for attaching a hooking device, or the functionaldevice itself.

FIG. 40B shows a fastener system 622 comprising fastener segments 623connected with segments of a bioresorbable material 625, as discussedherein, to ease installation. The fastener segments 623, illustratedwith a rough surface to indicate that they are also coated with a tissuegrowth promoting material, are surgically attached to the adjacenttissue wall. Each segment is also shown as having a hole or void 624that can be used for attaching a hooking device, or another device. Thebioresorbable segments 625, shown having a smooth surface, woulddissipate over time, leaving the fastener segments 623 in place tosupport a load. This device would be simple to install, and once thebioresorbable material has dissipated, it would have individual segments623 that could move independently of one another, and not transmit theseforces to other segments. The embodiments shown in FIGS. 40A and 40B arepreferably configured so that installation does not narrow thepassageway of the organ.

FIG. 41A shows an alternative fastener system 626 comprising an annularshaped member 627 wherein the surface of the annular shaped memberalternates between having tissue growth promoting materials 628 andnon-tissue growth promoting materials 629. This embodiment shows thesurface 629 of the annular shaped member that lacks tissue growthpromoting materials shaped to form a hanging or attachment platform foranother device by extending away from and then back into the tissuegrowth promoting surfaces 628. This attachment platform can be used forvarious items such as sutures, clips, rings, hooks, hangers, etc., thatcan depend form the attachment platform.

FIG. 41B shows an alternative fastener system 630 comprising an annularshaped member 631 wherein the surface of the annular shaped memberalternates between having tissue growth promoting materials 632 andnon-tissue growth promoting materials 633. In this embodiment, thesegments 632 of the device having the rough surface would be thesegments attached to the adjacent tissue wall. The coupled smoothsegments 633 are made from an elastic material that can be stretched, asillustrated with one segment 634 drawn tight. This configuration allowsthe attached rough segments 632 to move almost independently of oneanother, and also provides a platform from which a load can besupported, that platform being the entire annular shaped member 631.Whatever device is eventually coupled to the annular shaped member 631could be coupled using any or all portions of the annular shaped memberfor support. The embodiments shown in FIGS. 41A and 41B are preferablyconfigured so that installation does not narrow the passageway of theorgan.

FIG. 42A shows an alternative fastener system 635 comprising an annularshaped member 636 wherein the surface of the annular shaped memberalternates between having tissue growth promoting materials 637 andnon-tissue growth promoting materials 638. This embodiment shows thesurface 638 of the annular shaped member that lacks tissue growthpromoting materials to have hooks 639 extending from the plane of theannular shaped member 636. These hooks 639 can be used for attachinganother device or appliance. Also shown are holes 640 in this embodimentwhich may be used to pass a suture or other attachment structure, asdescribed herein, through to help secure the device in place. The hooks639 can be curled to retain other devices, or could have specific matingcouplings for example wherein a quarter turn will lock the coupling tothe hooks 639.

FIG. 42B shows an alternative fastener system 641 comprising an annularmember 642 of rough segments 643 having hooks 644 coupled to smoothsegments 645 that are made of a bioresorbable material. The roughsegments 643 are coupled to the adjacent tissue wall and remain in placeto support a load after the bioresorbable segments 645 have dissipated.This embodiment is thus simple to install, and enables each segment 643to move independently of one another once the bioresorbable smoothsegments 645 have dissipated.

The embodiment shown in FIGS. 42A and 42B are optionally configured sothat installation does not narrow the passageway of the organ.

FIGS. 43-45 show various embodiments of a fastener system that canoptionally function to create a stoma within a passageway that is morenarrow than the original passageway. The stoma can be created byplicating or pinching the tissue of the passageway such that it isfolded in the manner shown in FIGS. 43-46A. The folds are held in placewith the fasteners which pass through both tissue layers and hold themtogether. In addition, these fasteners also function as attachmentsurfaces for another device or devices, such as a clip supported by afastener, and a device supported from the clip.

The use of plications (folds) is often useful in overcoming thedifficulties of coupling a fastener device to a hollow walled organbecause the folds give the added strength of a double layer attachmentpoint, and also protect against leaks because the hole passes from theinside of the organ and back to the inside of the organ. Anotheradvantage is that the outermost wall of the gastrointestinal tract, theserosa, appears to heal well because when it is in contact with itself,such as within a fold, it tends to heal together. This will furtherserve to prevent leaks by sealing the channel formed by the placement ofthe fastener through the fold. Plications can be formed by a fastenersystem or can be formed by standard techniques such as sutures with afastener attached either to the suture or directly to the plicationafter it is formed. Alternately, plications can be formed and fastenersinserted that the fasteners pass through the muscularis layer of thegastrointestinal wall but do not pass through the serosa. This may beclinically preferred as a means to prevent leaks as the serosa providesa sealing layer. This also applies to the fasteners shown in FIGS. 47A-Fand 48.

FIG. 43 shows a fastener system comprising a hollow plication element646 that may be used to hold tissue together, as well as an attachmentelement 647 that is shown capable of passing through the hollowplication element 646 and snapping into place. The attachment element647 thus provides a platform for attaching other devices or hooks.Alternatively, a device may clip in directly to the hollow plicationelement 646, thus obviating the need for an attachment element 647. Thehollow plication element 646 could have a cone shaped end that is ableto pierce through the tissue layers, and this cone shaped end would thenexpand to remain in place.

FIG. 44 shows an alternative embodiment of a device similar to thedevice of FIG. 43, wherein the attachment element 648 differs. Theattachment element 648 is in the form of a wire clip that attaches tothe hollow plication element 646.

FIG. 45 shows an alternative embodiment of a device for both holding twolayers of tissue together and providing a platform from which anotherdevice or hanger can be attached. In this embodiment, the devicecomprises two components, a post 649 having an attachment platform, aswell as a snap cap 650 to hold the tissue layers together. Thisembodiment has a solid, rather than hollow element for connecting thetissue layers which may be advantageous in certain applications,especially where less tissue is available for folding, or where it maybe desirable to have the original diameter of the passageway kept aswide as possible. Note that though all fasteners in FIGS. 43-45 areshown passing through the serosa of both layers of the plications, thisis not a requirement of the devices or methods.

FIG. 46A shows an alternative embodiment of a fastener system. Thisembodiment includes a fastener 651 that can be made from a metal havingsuperelastic or shape memory characteristics such as Nitinol, so thatthe device can be loaded within a delivery device, such as a hypodermictube. Once the tissue has been folded, the fastener 651 can optionallybe sent through both tissue layers to hold them together to create astoma, and also optionally function to provide a platform for attachinganother device or hanging element. The curled portion 652 of the devicecan be straightened out and stored so that it lies essentially parallelto the post 653 that is positioned between the tissue layers. When thecurled portion 652 of the device is released from the delivery deviceand allowed to expand, it then forms a cone shaped spring to hold thetissue layers together. The relative dimensions of the cone shapedspring are exaggerated for illustration purposes. The cone shaped springdistributes force onto adjacent tissue over a relatively large area, andcenters that force onto the post. The cone also prevents the fastenerfrom being pulled through the hole. This particular geometry is intendedto be exemplary and other geometries which increase the area of theportion of the fastener which bears the weight (force) of the dependentdevice and thereby helps resist pull-through.

FIG. 46B shows the fastener device 651 of FIG. 46A being driven througha single tissue layer, with the attachment means 654 on the end of thepost 653 positioned within the passageway, and the cone shaped springpositioned 652 on the opposite side. The embodiment shown in FIG. 46B ispreferably configured so that its installation does not narrow thepassageway of the organ. Delivery of fastener embodiments communicatingwith the exterior of a hollow organ as shown in FIG. 46B (also FIGS.6B-D) may incorporate means to control capture of other structures.Though it may be clinically desirable to capture other structures as inthe case of capturing the diaphragm by fasteners placed in the cardia ofthe stomach it is more likely that this would be undesirable. Fasteningmeans could incorporate shielding means and/or means to invaginate theorgan wall as the fastener is advanced through the organ wall.

FIG. 47A shows a clip 655 that can be used to plicate tissue, and alsoprovide a platform for attaching another device or hanger. The clip 655is shown being used with one embodiment for a plication tool 656. Theplication tool 656 is capable of folding tissue in a desired way andthen delivering a clip 655 to hold the tissue in a folded configuration.This is accomplished by grabbing the wall of a tissue at two points, andthen pinching the wall (either with the tool itself or the fastener) anddelivering a clip 655 to hold the fold together. Various means may beemployed to ensure that the fold occurs properly, such as suction, orpushing the tool 656 into the tissue wall as it pinches.

FIGS. 47B-47D show the sequence of steps used to deliver the clip 655 ofFIG. 47A. This process may be repeated to collectively form a supportstructure for another device. The plication tool 656 may include suctionor other mechanical means such as hooks or barbs to encourage the tissueto fold as shown in the figures.

FIG. 47B shows a side view of the plication tool 656 loaded with a clip655. The clip 655 is positioned adjacent to a tissue wall, as shown.

FIG. 47C shows the clip 655 being compressed. The clips distal endspierce the adjacent tissue, and then fold it as the clip 655 iscompressed with the plication tool 656.

FIG. 47D shows the clip 655 being compressed further. The directionarrows above the plication tool 656 indicate that the plication tool 656could be biased towards the closed position with a spring mechanism, orthat some type of direct mechanical force could operate the tool.

The clip 655 may be designed so that it is normally closed or normallyopen. If the clip 655 is designed normally open, it will need to becompressed and remain compressed. Therefore, the clip 655 is preferablymade of a deformable or malleable material, such as an annealed metal,that can be deformed by the application tool 656 such that the clip willretain the deformed position. The tool 656 used to compress the cliptransmits force to close the clip 655, using for example, a wire or rodthat is optimized to transmit a push force to compress the clip.However, if the clip 655 is designed to be normally closed, it ispreferable that the clip 655 be made of an elastic material that can beopened up, and then close on its own or with the assistance of aplication tool 656. The plication tool 656 would need to be able to holda clip 655 that is normally closed in the open position, and should bedesigned to do such a task with an appropriately designed clip. Thenormally closed clip 655 may be preferred in some circumstances becauseit easier to hold tension in a tool and then release it than to transmitforce through a tool. The normally closed clip 655 will be easier topass into the body when closed and mechanisms to open the clip in vivocan be accomplished using pull wire actuators as well known in the art.

FIG. 47E shows another device 606 that is positioned to hang fromseveral clips 655 positioned within a passageway. The embodiment shownin FIG. 47E is preferably configured so that its installation does notnarrow the passageway of the organ. The vertical lines indicate thatthis device has been positioned within an organ, such as the stomach,such that the inner diameter of the device is not more narrow than theinner diameter of the tissue upstream of it, in this case the esophagus.

FIG. 47F shows an alternative clip embodiment 659 having two separateattachment platforms 657, 658. One platform 657 is positioned at thehinge portion of the clip 659, and a second platform 658 is positionedalong the bottom half of the clip 659, as shown in FIG. 47F. One or bothplatforms 657, 658 may be used, and the second platform 658 can beeasily repositioned on the clip, if desired. Note that if the sleevedevice 606 of FIG. 47E were supported by the second platform 658 of theclip 659 of FIG. 47F, a larger diameter sleeve device can be employed.

FIG. 48 shows another embodiment of a fastener 660 comprising a hanger661 that also functions to hold two layers of folded tissue together.This fastener has a toggle 662 that pivots on a hinge 663 so that is canbe aligned with the post 664 as it is passed through tissue layers, andcan then be pivoted to hold the tissue layers together.

The toggle 662 helps to distribute forces that hold the fastener 660 inplace over the length of the toggle 662, and also prevents the fastener660 from being pulled through the hole. Alternative to the toggle 662, asimilar functioning apparatus such as a multi-arm umbrella could also beused to distribute forces on the adjacent tissues while preventing thefastener 660 from passing through the hole. This fastener functionssimilarly to the T-tag fasteners described herein.

In summary the fastener system can include:

an implantable surface for mounting a functional element that may attachto the tissue itself with a suture, staple, clip, T-tag or pass throughone or more layers of tissue including a fold of tissue.

The fastener system, optionally including:

an interface element, and

a functional element, wherein the interface element couples theimplantable surface for mounting a functional element to the functionalelement.

The fastener system, optionally including:

a functional element, wherein the functional element couples to theimplantable surface for mounting a functional element.

The fastener system, optionally including:

a plication tool for folding a tissue wall such that the tissue wall ispinched and pulled toward the tool and the interior of a body organ, and

an implantable surface for mounting a functional element delivered bythe plication tool for maintaining the fold, and that also provides aplatform for attachment of another element.

The fastener system, optionally including:

a removal tool that can be used to remove a functional element by, forexample, unhooking it, cutting it, turning it, unlocking it.

A method for positioning the fastener system and using it can include:

attaching an implantable surface for mounting a functional element thatmay attach to the tissue itself with a suture, staple, clip, T-tag orpass through a fold of tissue,

optionally attaching one or more interface elements to interface betweenthe implantable surface for mounting a functional element and aremovable functional element, and

attaching a removable functional element that attaches either toimplantable surface for mounting a functional element itself, or to theinterface element.

A method for removing the functional element can include:

using a removal tool to remove the functional element by, for example,unhooking it, cutting it, turning it, unlocking it.

In the case of an attachment ring the ring does not necessarily create arestriction. In many embodiments, a second element generally creates arestriction using a restricting device (for example stoma 100). Therestriction may or may not be co-located with the attachment ring. Inthe case of the stomal ring clip (SCR) the ring clip creates therestriction by positioning natural tissue to create the restriction.Therefore they differ in that the SRC: 1) preferably uses tissue tocreate the restriction and 2) always has the restriction at itslocation. This is the case even where a sleeve is passed through thestoma created by an SRC. Please note that many apparatus (includingfastening systems) can be applied to either use and some could beapplied interchangeably. Please also note that the structures describedas an SRC can generally be used as components of an attachment ringsystem in which case the restriction is not necessarily collocated.

One aspect of present invention provides apparatus and methods forperforming gastric and esophageal surgery. The apparatus of theinvention includes a surgical instrument for creating a stoma orrestriction in a patient's stomach or esophagus using minimally invasivesurgical techniques. This apparatus can also be used to create aplication or fold in the stomach or esophagus and furthermore can thenbe used to attach other devices including those described herein, to thefold thereby created. The apparatus can also include stomal ring clipdevices implantable within the patient's stomach for forming andmaintaining the stoma or restriction. The surgical instruments and theimplantable stomal ring clip devices may be used separately or incombination depending on the needs of the individual patient. Methodsare described using the surgical instruments and the implantable stomalring clip devices separately and in combination for creating a stoma orrestriction in a patient's stomach or esophagus. The apparatus andmethods are useful for treatment of morbid obesity and can be combinedwith other surgical techniques or devices as part of a completetreatment regimen. The apparatus and methods are useful for treatment ofgastroesophageal reflux disease (GERD) by creating a restriction or avalve-like structure at the gastroesophageal junction to prevent refluxof the stomach contents.

FIGS. 49-51 illustrate a surgical instrument 700 constructed inaccordance with the present invention. The instrument 700 has anoptionally flexible elongated body 702 with a handle 704 on its proximalend. At the distal end of the flexible elongated body 702, the surgicalinstrument 700 includes a fastener delivery mechanism 708 and anarticulated arm 706 with means for grasping and plicating a portion oftissue, such as the stomach wall, and for fastening the tissue withrivets or similar fasteners 710. Optionally, as shown in FIG. 53, thedevice is sized to pass through the working channel of an endoscope. Thearticulated arm 706 is pivotally mounted on an extension arm 720extending from the distal end of the flexible elongated body 702.Optionally, the extension arm 720 may be extendable and retractable fromthe flexible elongated body 702. This option allows the articulated arm706 to capture varying sizes of tissue folds including those that canoptionally result in the fastener passing through layers of serosa. Thearticulated arm 706 has an anvil 722 for heading the rivets 710 and mayhave one or more spikes or teeth 724 for securely grasping the tissue.FIG. 49 shows the surgical instrument 700 with the articulated arm 706pivoted outward. FIG. 50 shows the surgical instrument 700 with thearticulated arm 706 pivoted inward toward the fastener deliverymechanism 708. FIG. 51 shows the surgical instrument 700 with thearticulated arm 706 heading or expanding a rivet 710. The articulatedarm 706 may be actuated from a control button 718 on the handle 704 bycables, rods or other actuation mechanism within the flexible elongatedbody 702. Optionally, the articulated arm 706 may be normally in theposition shown in FIGS. 2 and 3 and require actuation to open to theposition shown in FIG. 49.

The fasteners 710 may take one of several possible forms. The fasteners710 may be in the form of double-ended rivets with an expandable head onthe leading and trailing ends, as shown in FIGS. 49-51 and 55-57. Thefastener 710 is pushed through the tissue, then the expandable head onthe leading and trailing ends is expanded by the force of the anvil 722.Alternatively, the fasteners 710 may have a fixed head on the trailingend of the fastener and an expandable head on the leading end. Inanother alternative configuration, the fasteners 710 may be in the formof blind fasteners, of the type commonly known as pop rivets.Additionally, the fasteners 710 could be self-expanding so that oncepassed through the tissue of the stomach, they expand to hold theplicated stomach tissue together. These fasteners 710 may be biased, orspring loaded, so that minimal contact with the anvil causes thefastener to expand below the plicated tissue. In this embodiment,fasteners 710 could include a trailing end that self expands as it exitslumen 114 of FIG. 52 thereby capturing the tissue in a plication. Also,the fasteners could have a self-expanding end, and a non self-expandingend. Perhaps the non self—expanding end is already expanded, or could bemade to expand with additional force.

The fasteners 710 can be permanent or biodegradable. The fasteners 710may be constructed of a biocompatible metal or polymer or a combinationor composite thereof. Alternatively, the entire fastener 710 or aportion of it may be constructed of a bioresorable material.Additionally, the fasteners 710 can include enhanced scar forming meanssuch as a coating of lower that normal pH or a material such aspolyglactin (Vycril, Ethicon).

The articulated arm 706 section of the device can be configured tocapture varying sizes of tissue folds, with some embodiments enablingcapture of folds of greater dimension than the width of the device. Thismay involve use of curvilinear, bendable and/or multiple articulatedarms 106. In another embodiment the rivet lumen exit can be angled tocooperate with a larger articulating arm 706 to capture a larger fold oftissue.

The surgical instrument 700 is preferably configured for performingsurgery on the stomach or esophagus via a peroral endoscopic approach.As such, the flexible elongated body 702 may be sized and configured tofit through the instrument channel of a gastroscope or to fit throughthe patient's esophagus alongside a gastroscope. Otherwise, the flexibleelongated body 702 may be configured with a lumen or channel to accept agastroscope or other endoscope or imaging device through the surgicalinstrument 700. Alternatively, the surgical instrument 700 may bereversibly attached to or integrated with a gastroscope or imagingdevice.

FIG. 52 shows a cross section of one possible configuration of thesurgical instrument 700 shown in FIGS. 49-51. The flexible elongatedbody 702 has a first lumen or channel 712 for the articulated arm 706, asecond lumen or channel 714 for the fastener delivery mechanism 708 anda third lumen or channel 716 for passage of an endoscope or otherinstrument. The channel 714 for the fastener delivery mechanism 708 mayinclude a protrusion (not shown) that extends from the distal end of thechannel 714 to capture the holes in the stomal ring clip (describedbelow) to hold it in place, and assure that a fastener is deliveredaccurately through a stomal ring clip. In other embodiments, such asthat of FIG. 53, the articulated arm 706, and fastener deliverymechanism 708, can be passed down the lumen of an endoscope 702.

FIG. 53 shows a surgical instrument comprised of a fastener deliverymechanism 708, and an anvil attached to an extension arm 720 with ahinge or hinge-like structure, used for creation of a stoma orrestriction in a patient's stomach that is sized for passage through anendoscope. The extension arm 720 in this embodiment is shown to curveaway from the fastener delivery mechanism 708 so that the surgicalinstrument can plicate a greater amount of stomach tissue. This allowsthe fastener to gain the advantage of passing through two completelayers of stomach tissue because the fastener is no longer near the edgeof the fold. The surgical instrument is inserted within an endoscope730. The endoscope has been introduced into the patient's mouth and downthrough the esophagus into the patient's stomach. The surgicalinstrument is then passed through the endoscope 730. The articulated arm706 is pivoted outward, as shown in FIG. 49, to grasp a portion of thestomach wall using the spike 724. The articulated arm 706 is thenpivoted toward the fastener delivery mechanism 708, as shown in FIG. 50,to plicate or fold the stomach wall. The rivet or fastener 710 is driventhrough the fold in the stomach wall, and the anvil 722 on thearticulated arm 706 heads or expands the rivet or fastener 710 to securethe tissue fold as shown in FIG. 53. The surgical instrument 700 isrotated, independently or with the endoscope, and the process isrepeated to place a series of fasteners 710 in a circular pattern toform a stoma or restriction in the patient's stomach as shown in FIG.54, perhaps moving to the opposite side of the stomach from the previousfastener, rather than to an adjacent position, to create a uniformstoma. In the example shown, when the stoma forms a restriction, thestoma is typically sized between one half and two centimeters indiameter, to restrict food intake into the stomach for treatment ofmorbid obesity. Alternatively, the surgical instrument 700 may be usedto create a valve-like flap at the gastroesophageal junction fortreatment of gastroesophageal reflux disease.

FIGS. 55-57 show the sequence of steps for inserting a fastener 710 ingreater detail. These figures also illustrate one embodiment of afastener 710 having a pointed cone-shaped distal end to allow it to beeasily passed though stomach tissue, and perhaps a stomal ring clip (asdiscussed below).

FIG. 55 shows the spike 724 positioned on the terminal end of the anvil722. The articulated arm 706 is initially extended parallel to theextension arm 720. The spike 724 is then moved toward the stomachtissue. Once the spike 724 has gotten hold of the stomach tissue, theanvil 722 is rotated toward the fastener delivery mechanism 708, asshown in FIG. 56.

FIG. 56 shows the distal end of the fastener 710 in the expandedposition. As previously discussed, this fastener 710 could beself-expanding, whereupon contact with the anvil 722 forces the fastener710 to expand. In this figure, the spike 724 is shown to engage thebiased spring of the fastener, which then expands with the impetusprovided by the force of pushing the fastener 710 over the spike 424. Inthis embodiment, the proximal end of the fastener 710 is self-expandingand expands as soon as it exits the delivery lumen 708. Alternatively, atrigger (not shown) may be provided within the fastener 710 that allowsthe distal end of the fastener to expand. This same trigger mechanismmay then encourage the proximal end of the fastener 710 to expand oncereleased from the fastener delivery lumen.

FIG. 56 also shows the curved extension arm 720 in proximity to thestomach tissue. If necessary, the curved extension arm 720 could preventthe stomach tissue from expanding back over the distal end of thefastener prior to the fastener's release from the fastener deliverylumen.

FIG. 57 shows the fastener 710 in situ. The fastener delivery lumen 708is retracted, as is the anvil 724. The process is repeated in a circularpattern to create a stoma as in FIG. 54.

FIG. 58 shows an example of a stomal ring clip device 740 with only anupper ring 742 implanted in a patient's stomach, held in place withfasteners 746. It should be noted that a ring can be used either aboveor below the tissue plication. The stomal ring clip device 740 helps tomaintain the dimensions of the stoma that is formed by resistinginadvertent or deliberate stretching of the stomal opening, adding tothe overall success of the treatment. The stomal ring clip isconstructed from a material that will resist the forces that couldstretch the stomal opening beyond its intended dimension. Alternatively,the material can be elastic and be selected to resist most stresses andif stretched return the stomal opening to its original size.

FIG. 58 also illustrates the placement of a stomal ring clip devicerelative to the plicated stomach tissue, showing that the plicatedstomach tissue diameter is actually narrower than the stomal ring clip'sinner diameter, in some embodiments. This type of placement has theadded advantage of allowing for a variable stomal diameter. For example,the plicated stomach tissue may have a diameter of 1 cm, and the innerdiameter of the stomal ring clip may be 2 cm. The plicated stomachtissue's diameter can expand if necessary, up to the diameter of thestomal ring clip. This allows a patient who inadvertently swallows alarge piece of food to have a larger stomal opening to accommodate thatlarger piece of food. The inner diameter of the stomal ring clip couldbe made large enough to accommodate anything that makes it down theesophagus, while the plicated stomach tissue's diameter could be madesmall enough to slow the rate of consumption and increase the feeling ofsatiation, leading to a decrease in the amount of overall foodconsumption for the patient, and thus resulting in weight loss.Alternatively, the diameter of this tissue can be sized to create littleor no restriction to food flow as discussed herein.

FIGS. 59-64 show a sequence of steps for using a surgical instrument 700to implant a stomal ring clip device 740 similar to the stomal ring clipdevice of FIG. 58.

In one method of application, the ring 742 of the stomal ring clipdevice 740 is rolled or folded and passed into the patient's stomachthrough the patient's esophagus or through a sleeve temporarily placedin the esophagus to protect the esophagus or through the instrumentchannel of an endoscope or surgical instrument 700. The ring 742 is thenallowed to return to its flat state within the patient's stomach, asshown in FIG. 59. FIG. 59 also shows an embodiment of a surgicalinstrument 700 for attaching the stomal ring clip positioned at the topof the stomach. In this embodiment, the surgical instrument 700 has anadditional feature for retrieving the stomal ring clip. It is comprisedof three prongs 743 that can be used to grasp a stomal ring clip. Twoprongs 743 grasp the stomal ring clip's inner surface, preferablygrasping the clip on either side of a lobe. The third prong 743 graspsthe outside surface of the stomal ring clip and opposes the graspingforce from the inner two prongs. Also, the third prong 743 is shown tohave a spike 745 on it. The spike 745 may be used to oppose the forcecreated by the upwardly moving articulated arm 706 (refer to FIG. 62).The prongs 743 may also curve at their terminal ends to improve theirgrip on the stomal ring clip. The prongs 743 can be retracted andextended within their respective lumens, and also can be moved inwardand outward to grasp and release the stomal ring clip 742. In someembodiments, only the inner or outer prongs may be moved inwardly oroutwardly.

FIG. 60 shows a surgical instrument 700 holding a stomal ring clip 742.In this embodiment, the surgical instrument 700 is shown to grasp astomal ring clip 742 having lobes. The lobes may be useful forincreasing the surface area around the preformed holes in a stomal ringclip, or for increasing the surface area for a fastener to make contactwith in embodiments of a stomal ring clip not having preformed holes (inthese embodiments, the stomal ring clip is made from a material that maybe pierced by the fastener as it is being deployed). Another use for thelobes is to aid in the orientation of the stomal ring clip relative tothe fastener delivery mechanism. In this embodiment, the fastenerdelivery mechanism would be aligned over the lobe area for placement ofa fastener.

FIG. 61 shows the next step of the process in which the stomach tissueis folded. The extension arm 720 and anvil 722 are deployed, extendingthrough the interior of the stomal ring clip 742. The anvil is able topivot so that it moves away from the stomal ring clip to avoid catchingthe spike, and then pivot in the opposite direction to engage thestomach tissue. It should be noted that the spike is shown relativelylarge in this embodiment for illustration purposes. It should also benoted that a spike may be positioned elsewhere on the device relative tothe anvil, such as is shown in FIG. 49.

FIGS. 59-64 show an embodiment of the surgical instrument 700 forattaching the stomal ring clip positioned at the top of the stomachabove a plication. Alternatively, if it is desirable to attach a stomalring clip below the plication, grasping prongs could be placed on thearticulating arm. In this case, secondary grasping means can be used toassist in positioning stomach tissue to form the plication prior tofastening.

FIG. 62 shows the anvil 722, with the spike 724 engaging adjacentstomach tissue, and beginning to be rotated toward the stomal clip 742,thus folding the stomach tissue.

FIG. 63 shows the next step of the procedure, comprising the delivery ofa fastener 710. Note that the spike 724, or additional spikes, may bepositioned elsewhere along the anvil 722 or articulated arm 706 tofacilitate the formation of the plication.

FIG. 64 shows a close-up view of a single fastener 710 in place.

The device is then used to plicate additional stomach tissues and insertfasteners 710 as described before, perhaps moving to the opposite loberather than to an adjacent lobe on the stomal ring clip 742, to create auniform stoma.

FIG. 65 is an exploded view of a stomal ring clip device 740 havingupper 742 and lower 744 rings for forming a stoma or a restriction in apatient's stomach. FIG. 65 shows an alternate embodiment of the rivets746 in which the rivets are blind fasteners of a “pop rivet” typeconfiguration where instead of the distal head of the rivet beingexpanded by pressing against an anvil, the rivets include an internalexpander which is drawn proximally into the rivet to expand its distalend. In this configuration, the rivet delivery lumen 714 can includegrasping and articulating means to deploy the rivet expander, hold therivet in place as the expander is drawn proximally, and then remove theundesired portion of the expander after deployment. The undesiredportion of the expander could be caught with a magnet or some othermeans, and then retracted. As previously stated, other types offasteners could also be used, for example double-ended rivets,single-ended rivets or rivets designed to expand with anvils withoutspikes.

FIG. 66 shows an assembled view of the stomal ring clip device 740 ofFIG. 65 implanted in a patient's stomach. The stomal ring clip device740 is configured to be implantable within the patient's stomach using aperoral endoscopic approach with the surgical instrument 700 of FIGS.49-51, or one of the other embodiments discussed. Alternatively, thestomal ring clip device 740 may be implanted with standard endoscopicinstruments or it may be implanted via alaparoscopic approach or acombined endoscopic and laparoscopic approach. The stomal ring clip canbe fastened in place using open surgery, laparoscopic techniques,standard endoscopic suturing techniques or use specialized sewingdevices such as the ENDOCINCH″ (CR Bard Inc.) or others describedherein. The stomal ring clip device 740 includes an upper ring 742, aplurality of fasteners 746 and, optionally, a lower ring 744. The upperring 742 and the lower ring 744 are generally flat and have an innerdiameter and an outer diameter. The inner diameter is preferably largerthan the diameter of the desired stoma opening such that the foldedtissue rather than the stomal ring clip material form the actual stomaopening. This would result in an inner diameter of approximately one tothree centimeters. The width of the stomal ring clip is dimensioned toallow placement of attachment means and may include ribs or ridges torestrain the tissue captured in the folds between the rings. In oneembodiment, both the upper ring 742 and the lower ring 744 are made of aflexible, resilient material that can be folded or rolled to a diametersmall enough to be delivered easily through the patient's esophagus orthrough the instrument channel of an endoscope or surgical instrumentand which will return to its flat state for deployment in the patient'sstomach. Suitable materials for the upper ring 742 and the lower ring744 include resilient metals, such as spring-tempered stainless steeland superelastic NiTi alloys, and resilient polymers (fluoropolymers,polypropylene, polyethylene, nylon or Pebax), elastomers (silicone,polyurethane) or composites or reinforced versions thereof. Commerciallyavailable materials such as Goretex (Gore) or Marlex (Davol) mesh couldalso be configured for use as a stomal ring clip. Materials can bepermanent or biodissolvable. Though it is preferable for the rings to beresilient and have the ability to be folded or rolled, the rings couldbe made of rigid material (e.g. titanium or rigid plastic such aspolyester) and be designed with hinges or articulations to allow passagethrough the esophagus after which, upon entering the stomach, they couldbe opened to their full size prior to attachment. Alternatively, thestomal ring clip may be constructed of sections made of rigid materialsconnected by sections of flexible material.

FIG. 67 shows an example of a stomal ring clip device 740 with an upperring 742 and a lower ring 744 implanted in a patient's stomach. In thisexample, the stomal ring clip device 740 has a diameter smaller than thediameter of the opening formed by the plicated tissue.

The upper ring 742 and the lower ring 744 optionally have a plurality ofpreformed holes sized to accept the plurality of fasteners 746. In oneembodiment, the plurality of fasteners 746 are in the form of rivets orsimilar fasteners that are deliverable using the surgical instrument 700of FIGS. 49-51. Alternatively, the fasteners 746 can be integrated intoone or both of the rings 742, 744 so that the two can be fastenedtogether without separate fasteners. Alternately fasteners and holes canbe designed so the fasteners secure themselves to the rings as they areplaced through the ring material. This can obviate the need for anexpandable distal head on the fastener. Similarly, the proximal head ofa fastener can be dimensioned larger than the shaft of the fastener andthe hole through which the shaft passes in the upper ring therebyobviating the need for an expandable proximal head. Alternatelyconstructing the rings 742 and/or 744 of a pierceable material, such asGoretex or Marlex or materials commonly used for vascular grafts orother materials described herein, would allow a fastener of anappropriate piercing design would allow implantation without requiringthe lining up of preformed holes.

In a variation of the method for placing a single ring, a lower ring 744may be passed into the patient's stomach prior to the upper ring 742. Asurgical instrument, which may be inserted laparoscopically, holds thelower ring 744 from below, while another instrument, insertedendoscopically, holds the upper ring 742. The stomach wall is plicatedor invaginated between the upper ring 742 and the lower ring 744 and thefasteners 746 are driven through both rings, effectively sandwiching afold of the stomach wall tissue between the two rings. FIG. 67 shows anexample of a stomal ring clip device 740 with an upper ring 742 and alower ring 744 implanted in a patient's stomach.

These apparatus and methods can be combined with other surgicaltechniques or devices described above as part of a complete treatmentregimen for treatment of morbid obesity. By way of example, FIGS. 68 and70 show two embodiments of gastrointestinal sleeve devices 750 attachedby stomal ring clip devices 740. These sleeve devices 750 interrupt thedigestion process by delaying various digestive juices from interactingwith ingested food until the food reaches a desired location in theintestine.

FIG. 69 shows the device of FIG. 68 in situ. The sleeve portion 750 ofthe device is attached to a lower stomal ring clip 744. The sleeve 750is flexible as described herein, allowing it to conform to the variouscurves involved with the gastro-intestinal (GI) tract. The sleeveportion 750 of the device may also be compressible, collapsible orfoldable, allowing the pyloric sphincter to open and close, as well asexpandable for larger pieces of food. In this embodiment the sleeve 750is attached to the outer diameter of the lower stomal ring clip 744thereby allowing the suturing or fastening device access to the stomalring clip 740 for fastening without damaging or piercing the sleeve 750.This type of sleeve 750 is generally placed at the same time as thestoma, however the sleeve 750 and stomal ring clip 740 can beconstructed with removable and replaceable connections for the exchangeof sleeves on a previously implanted stomal ring clip.

FIG. 70 shows an embodiment for a sleeve device 750 that may be usedwith an existing stoma or stomal ring clip 740. The sleeve device 750 ismade of a flexible material like the device of FIGS. 68 and 69, and isattached to a ring or connector 751 constructed to have a rigiditygreater than that of the sleeve 750 and having a diameter that is largerrelative to the stoma and preferably larger than the inner diameter ofthe upper stomal ring clip 742, thus preventing the sleeve device 750from slipping through the stoma and moving downstream within the GItract. These sleeve devices 750 provide for a variable stomal diameter.For example, the devices shown are in a non-stressed state, and thesleeve can be made of a flexible or elastomeric material, and in thiscase the diameter of the stoma can actually increase if stretched by alarge piece of food. This type of sleeve 750 is generally placed afterthe stoma or stomal ring clip 740 is positioned. This can facilitateexchange of sleeves, for example, if a longer sleeve is considereddesirable. In some embodiments the ring connector 751 on the sleeve 750will attach and secure to the upper stomal ring clip 740.

FIG. 71 shows the device of FIG. 70 in situ. The sleeve device 750 shownin FIG. 70 can be used with a stoma (either created with fastenersalone, or created with fasteners and a stomal ring clip device 740) topass food from the mouth to someplace downstream within the GI tract,thus preventing the digestion.

An added benefit of the device of FIG. 70 is that when positioned in thestomach, as shown in FIG. 71, the sleeve device 750 can completely covera stoma ring clip 740, and thus prevent food from getting stuck andcaught up in the ring and fasteners, thus improving the flow of foodthrough the stoma.

The devices may be positioned as follows, after the stoma is created (aspreviously discussed), a sleeve device is then passed through the mouthand into the stomach (as previously discussed for a stomal ring clip),and then the distal portion of the sleeve device is passed through thestoma and preferably past the pylorus and duodenum and the distal end iscarried downstream within the GI tract (either pushed or viaperistalsis), and the proximal end is eventually left to sit atop thestoma. The sleeve can be dimensioned, as described herein, to locate therestriction to food flow at the stomal ring clip or at some other moredistal location. In other embodiments the sleeve diameter will notcreate the restriction and the restriction will use the pylorus as anatural restriction or the restriction will be created at the stoma ringclip. For additional security, the proximal end may be attached to thestoma by some means, perhaps clicking into place on a stomal ring clipdesigned to accept the proximal end of a sleeve device, sutured intoplace or attached using one of the other structures described herein.

FIG. 72 illustrates another embodiment of a surgical instrument 760 forfastening tissue. In one embodiment, the surgical instrument 760 ismounted on the exterior of a gastroscope or other flexible endoscope 730with a mounting ring or clamp 762. The surgical instrument 760 has anarticulated arm 764 with a plicator/riveter support 766 having a pair ofspaced apart support fingers 768 mounted to it. A flexible control cable772, which extends to the proximal end of the gastroscope 730, allowsthe operator to move the articulated arm 764 and plicator/rivetersupport 766 axially and radially with respect to the gastroscope 730. Incertain embodiments, the support fingers 768 include one or moreretractable tines 770 for grasping and manipulating the tissue.Rivet-like surgical fasteners 780 are delivered with an insertion pushertube 774 through the working channel 732 of the gastroscope 730.

FIG. 73 is an exploded view of a rivet-like surgical fastener 780 foruse with the surgical instrument of FIG. 72. The surgical fastener 780has two components a rivet tube 782 and a rivet cap wire 788. The rivettube 782 can be made of a biocompatible polymer or metal. The rivet tube782 has a tapered distal end 786 an internal lumen 784 sized to allowpassage of the rivet cap wire 788 in a straightened condition. In itsdeployed condition, the rivet cap wire 788 has a straight piercingsection 796 on its distal end, followed by the distal button 792, whichis a section of the wire formed into a circle or spiral. Next, is astraight central section 790 that connects the distal button 792 to theproximal button 794, which is another section of the wire formed into acircle or spiral. In certain embodiments, the rivet cap wire 788 is madeof a highly resilient material, for example a superelastic NiTi alloy,which can be preformed into this geometry by cold working and/or heattreatment, and which will return to this geometry after beingstraightened out for insertion through the internal lumen 784 of therivet tube 782. Rivet tube 782 can be constructed of a relativelybioinert material such as 304 or 316 SS or Ti unless the clinicalsituation suggests that a material that encourages a scar forminghealing response as discussed earlier is desirable. Rivet tube 782 willtypically have an outer diameter of approximately 0.25-1.5 mm with theinner diameter large enough to provide for passage of a pre-formed NiTiwire of approximately 2×-6× the diameter of the wire. The tapered tipwill preferably have a minimum clearance to allow free passage betweenits inner diameter and the outer diameter of the NiTi wire. Wallthickness of tube 782 will typically be on the order of 0.002-0.005″.

FIG. 74 shows the surgical fastener 780 of FIG. 73 in a deployedcondition. The straight central section 790 of the rivet cap wire 788extends through the internal lumen 784 of the rivet tube 782, and thedistal button 792 and proximal button 794 are formed into asubstantially planar tissue-retaining geometry approximatelyperpendicular to the rivet tube 782 at the proximal and distal ends ofthe rivet tube 782. The straight piercing section 796 may be bent inwardslightly so that the distal button 792 protects it from inadvertentlypiercing any adjacent tissue structures when in the deployed condition.

FIGS. 75A-75F show a sequence of steps for deploying the surgicalfastener 780 of FIGS. 73 and 74. The tines 770 of the plicator/rivetersupport 766 grasp the tissue to be fastened, for example the stomachwall, and the articulated arm 764 draws it toward the gastroscope 730 toplicate the tissue. The support fingers 768 of the plicator/rivetersupport 766 are positioned astride the working channel 732 of thegastroscope 730. A surgical fastener 780 is advanced through the workingchannel 732 of the gastroscope 730 by the insertion pusher tube 774. Thesurgical fastener 780 is positioned with the tapered distal end 786 ofthe rivet tube 782 facing distally and the rivet cap wire 788straightened out and inserted through the insertion pusher tube 774 andthrough the internal lumen 784 of the rivet tube 782 with the straightpiercing section 796 extending slightly beyond the distal end of therivet tube 782.

The straight piercing section 796 of the rivet cap wire 788 pierces theplicated tissue, as shown in FIG. 75A. Then the insertion pusher tube774 pushes the tapered distal end 786 of the rivet tube 782 through thetissue, as shown in FIG. 75B, until the rivet tube 782 has passed allthe way through the tissue, as shown in FIG. 75C. Next, the rivet capwire 788 is advanced until the distal button 792 reforms to retain theplicated tissue the distal end of the rivet tube 782, as shown in FIG.75D. The insertion pusher tube 774 is then withdrawn, as shown in FIG.75E, allowing the proximal button 794 to reform to retain the plicatedtissue the distal end of the rivet tube 782. The fully deployed surgicalfastener 780 holding the plicated tissue is shown in FIG. 75F.

The construction of the surgical fastener 780 allows it to be removed ifit is desired to reverse or revise the surgical procedure. FIG. 76 showsthe surgical fastener 780 of FIG. 73 being removed. A grasping tool orother rivet tube retaining tool 752 engages the proximal end of therivet tube 782 and a grasper 756 grasps the rivet cap wire 788 near itsproximal and withdraws it from the rivet tube 782 to release thefastened tissue.

The attachment device and fasteners described in FIGS. 72-76 share manyattributes with the attachment device and fasteners described in FIGS.49-65. With appropriate design adjustment features of the attachmentdevices and fasteners can be combined and/or interchanged.

FIGS. 89A-89D shows an alternate rivet design 870 in which the rivettube 872 is provided with an attached or formed in place proximal rivetcap 874. The proximal rivet cap 874 can be formed as described earlieror formed as shown in FIG. 89A. FIG. 89B shows a multi fingered distalcap 876 that can be deployed by an axial advancement of the fingers, asshown in FIG. 89C. With a design that includes a proximal eye or othermeans of coupling, the fingers could also be retracted back into therivet body 872 if so desired. The fingers 876 of this rivet do notrequire the degree of superelasticity of the rivets described in FIGS.72-79 and could optionally be made from 304, 316 or other stainlesssteels in addition to NiTi alloys, as well as other metals. FIG. 89Dshows an exemplary apparatus 878 for deploying this type of rivet.

FIG. 77 shows a top view of an attachment ring device 800 for attachinga gastrointestinal sleeve device within a patient's stomach. FIG. 78shows a cross section of the attachment ring 800 of FIG. 77 attached ata plication formed in a stomach wall of a patient. The attachment ringdevice 800 provides strain relief to distribute the stress of attachmentto a substantial area of the stomach wall. The attachment ring device800 has a first, outer ring 802 that engages and seals against thestomach wall. A second, slightly smaller diameter ring 804 is connectedto the first ring 802 by a first annular sheet of material 806 that cansupport and seal to the sleeve interface. The first ring 802 and thesecond ring 804 are preferably wire-reinforced plastic rings. Suitablematerials for the first annular sheet of material 806 include, but arenot limited to, polyurethane, silicone and Teflon. Inside of the secondring 804 is a second annular sheet of material 808 that is easilypierced with a surgical fastener, such as the surgical fastener 780previously described, or other surgical rivet, staple or suture.Suitable materials for the second annular sheet of material 808 include,but are not limited to, Teflon fabric, Goretex or Marlex or materialscommonly used for vascular grafts. The second annular sheet of material808 may be slit or perforated to enhance the flexibility of the fabric.

FIG. 79 shows a cross section of the attachment ring device 800 of FIG.77 with a gastrointestinal sleeve device 400 installed. Thegastrointestinal sleeve device 400 has a sleeve ring 810 that is sizedto have a diameter slightly smaller than or the same size as the firstring 802 and slightly larger than the diameter of the second ring 804.The sleeve ring 810 is preferably a wire-reinforced plastic ring thatmay be somewhat more rigid than first ring 802 and the second ring 804.For installation, the sleeve ring 810 is compressed slightly so that itcan slip past the first ring 802, then it is allowed to expand so thatit engages and seals against the first annular sheet of material 806between the first ring 802 and the second ring 804.

Some configurations of attachment rings, such as the one illustrated inFIG. 79, could be placed with a stapling device similar to circularanastomotic staplers. In this method, the stapling device would beplaced via a peroral route with the attachment ring preferablypre-positioned on the stapling device. The device would then usesuction, stay sutures or other mechanical means to draw gastric wallinto the gap between the anvils of the stapling device in a manner thatforms a plication adjacent to the attachment ring. Dimensioning of thedevice can be selected to obtain stapling within the muscularis or afull thickness plication that also goes through the serosa as indicatedby the clinical situation. Firing of the stapling device would thenresult in an attachment similar to that shown in FIG. 78 with thesubstitution of the rivet as shown with one or more rows of staples. Oneembodiment of the stapling device would include a tilting or collapsibledistal anvil that could be withdrawn through the stapled in-placeattachment ring after the completion of the stapling procedure.Buttressing of the staples with bovine or porcine tissue, Teflon pledgesor other buttressing material, may be indicated in some clinicalsituations.

A leak shield may be used with any of the gastrointestinal sleevedevices described herein to help assure an adequate seal between thesleeve and the stomach wall at the proximal end of the device. The leakshield may be a separate component or it may be integral to thegastrointestinal sleeve device or to the attachment device. FIG. 80shows a cross section of the attachment device 800 and thegastrointestinal sleeve device 400 of FIG. 79 with an optional leakshield 812 installed. The leak shield 812 in this example is constructedintegrally with the gastrointestinal sleeve device 400. The leak shield812 is a tubular extension of the gastrointestinal sleeve device 400that has a resilient leak shield ring 814 at its proximal end. The leakshield ring 814 is preferably a wire-reinforced plastic ring. The leakshield 812 may be made of the same material as the gastrointestinalsleeve device 400 or, more preferably, it may be made of a materialchosen for its ability to provide a reliable seal against the stomachwall such as silicone, polyurethane or other flexible film. It would beexpected that the material of the leak shield would generally be ofequal or greater flexibility and equal or lower durometer than thesleeve due to the desire for it to conform and seal as well as the lowerforces it would be expected to withstand without failure.

FIG. 81 shows a top view of another embodiment of an attachment ringdevice 820 for attaching a gastrointestinal sleeve device within apatient's stomach. FIG. 82 shows a side view of the attachment ringdevice 820 of FIG. 81, which, by way of example, is shown attachedbetween two plications formed in a stomach wall of a patient. Theattachment ring device 820 could alternately be attached to a singleplication. The attachment ring device 820 has a first, outer ring 822that engages and seals against the stomach wall. A second, slightlysmaller diameter ring 824 is connected to the first ring 802 by a firstannular sheet of material 826 that is easily pierced with a surgicalfastener, such as the surgical fastener 780 previously described, orother surgical rivet, staple or suture. A third ring 830 is connected tothe first ring 802 by a second annular sheet of material 828 that cansupport and seal to the sleeve interface. The first ring 822, secondring 824 and third ring 830 are preferably wire-reinforced plasticrings.

The double plication illustrated in FIG. 82 as a structure and method ofattaching a device can be a preferred embodiment in certain clinicalsituations. As mentioned previously in relation to FIGS. 43-45 the useof a plication can confer certain advantages to an attachment structureand method. All of these advantages also exist with a device attachedbetween a double plication. The geometry created by the capture of adevice in a double plication is analogous to the placement of an o-ringin a grove. Though not 100% encapsulation, tissue would be in contactwith the implanted ring on three sides that would improve the leakresistance of the attachment. The use of the double plications wouldalso serve to stabilize the attachment and result in a favorabledistribution of forces that might be transmitted to the ring as a resultof its connection to a sleeve and/or stoma. A further advantage of thedouble plication attachment would be the doubling of the tissueattachment area. This would serve to distribute the forces transmittedto the ring over double the area resulting in a lowering of the pressureapplied to the tissue. Clinically, suture and other attachment failurecan often be attributed to localized ischemia and ischemia can berelated to the pressure applied to the tissue by the suture or fastener.Therefore, if a double plication may reduce the pressure transmitted tothe tissue by the attachment means, attachment failure will be reduced.

In a related aspect of an embodiment that could be clinically preferred,one should consider that when suturing or otherwise securing anattachment ring or other device in place it is beneficial to reduce thepressure transmitted to the tissue. This has been discussed previouslyrelated to the use of force distributing pledgets, fastener structuresand rivet end caps. These previously discussed structures and methodsrelate to reducing pressure along the axis of the fastener system. Thedouble plication addresses pressures that are perpendicular or radial tothe axis of the fastener. Increased fastener diameter would serve toreduce pressures in this direction however one can imagine that thiswould eventually have diminishing returns, as the area of tissueavailable to resist these forces would eventually be reduced below anoptimum level. With single and double plications and a fastener systemthat uses thin wires or sutures approximately between 0.2 and 0.5 mm indiameter or less, a simple method and structure to reduce pressure wouldbe use of an increased fastener density. In particular, use of pairedparallel fasteners is well suited to this end. One method would apply asingle continuous suture or wire that passed through all layers to befastened and then secured at one point. Of course two separate suturesor wires could then be secured to each other on either side of thelayers to be attached. Alternately, the two separate sutures or wirescould be secured by, and/or to, a common end cap. A pair of thin rivetscould also use a common end cap to achieve this end.

In another aspect the embodiment of FIGS. 81 and 82 can be modified toinclude two or more easily pierced material faces 826 and theirassociated rings 822. For example, using a 3 faced ring in the doubleplication attachment of FIG. 82 where the material faces are sandwichedaround both plications such that rivets 780 would pierce 3 layers of theface material in addition to 4 layers of stomach wall. In FIG. 91B a 2faced ring is shown attached with a T-pledget fastener as describedherein. In an alternate variation the attachment ring shown in FIGS. 77and 78, the easily pierced material 808 can be lengthened to asufficient length to fold over the plication and be in a position tobuttress the rivet 780 in FIG. 78 on both sides of the plication. Otherstructures can accomplish the same result.

In an additional aspect of the method of using the attachment ring shown820 in FIGS. 81 and 82, FIG. 91A shows how this type of attachment ringcould be attached using a transmural T-Tag 918. In some clinicalsituations it may be desirable to have additional attachment in whichcase one method to achieve this result would be to use two rows ofT-tags 918 in a variation of what is shown in FIG. 91A. In this examplethe material face 826 (between rings 822 and 824) can have an increasedwidth to provide additional room for the attachment of the additionalrow of T-Tags.

FIG. 83 shows a cross section of the attachment ring device 820 of FIG.81 with a gastrointestinal sleeve device 400 installed. Thegastrointestinal sleeve device 400 has a sleeve ring 810 that is sizedto have a diameter slightly smaller than or the same size as the secondring 824 and slightly larger than the diameter of the third ring 830.For installation, the sleeve ring 810 is compressed slightly so that itcan slip past the second ring 824, then it is allowed to expand so thatit engages and seals against the second annular sheet of material 828between the second ring 824 and the third ring 830. Optionally, anintegral or separate leak shield may be used with this embodiment of theattachment ring device 820.

Optionally, magnets can be used to facilitate alignment of theattachment ring device 820 and the gastrointestinal sleeve device 400.One or more magnets would be positioned in the attachment ring device820 and an equal number of magnets, arranged with opposite poles facing,would be positioned in the gastrointestinal sleeve device 400, When theattachment ring device 820 and the gastrointestinal sleeve device 400are moved into proximity with one another, the magnets cause the twocomponents to align automatically. The magnets will also help to createand maintain a seal between the two components.

The structures and methods associated with FIGS. 77-83 can also beapplied to other attachment methods and structures as described herein.Examples include 1) incorporating the structure of FIG. 77 or 81 couldbe incorporated into a stoma ring clip; 2) attaching these rings withT-tags in place of rivets and 3) use of multiple rows of attachment inplace of a single row as shown.

FIGS. 84A-84C show a gastrointestinal sleeve device 400 with an integralleak shield 812 similar to that shown in FIG. 80. FIG. 84A shows a crosssection of the proximal end of the gastrointestinal sleeve device 400with the leak shield 812 in a deployed position. In some clinicalsituations, the leak shield ring 814 has a diameter slightly larger thanthe diameter of the sleeve ring 810. For installation, the leak shieldring 814 is compressed slightly and stuffed past the sleeve ring 810into the proximal end of the gastrointestinal sleeve device 400, asshown in FIG. 84B so that it will not interfere with the installation ofthe sleeve ring 810. Once the sleeve ring 810 has been installed in thechosen attachment ring device, a grasper 734 is inserted through theworking channel 732 of the gastroscope 730 to grasp the leak shield ring814 and pull it out of the gastrointestinal sleeve device 400 to thedeployed position, as shown in FIG. 84C.

FIG. 85 illustrates the components of a kit for delivering and deployinga gastrointestinal sleeve device. In one embodiment, the kit includes anoptional guidewire 840, a pyloric/duodenal introducer 850, and either adistal pusher catheter 852 or a distal balloon seal 856 and pushercatheter 854. A balloon catheter 860 for removal of the gastrointestinalsleeve device may be included as part of the kit or supplied as aseparate item. For example this balloon catheter can be used forretrieval as described in step 12 of the method outlined below. As analternative to the use of a balloon catheter for retrieval, anendoscopic grasper such as those in the MAXUM line (Wilson-Cook) can bepassed coaxially down the sleeve or delivered externally to the sleevethrough the working channel of an endoscope then clamped onto the sleeveat some distal location and then used to retract the distal sleeve.

The pyloric/duodenal introducer 850 has a tubular body 844 with anintroducer lumen 846 sized to pass through the gastrointestinal sleevedevice. The tubular body 844 has a length sufficient to reach past thepatient's pylorus into the duodenum via a peroral route. In certainembodiments, the tubular body 844 has a slit flowering distal end 848for atraumatic crossing of the pylorus. An optional distal infusionlumen 842 parallels the introducer lumen 846 and allows infusion offluids near the distal end of the introducer 850. For example, theintroducer can be used as described in step 10g of the method outlinedbelow.

FIGS. 86A-86C illustrate three options for preloading a gastrointestinalsleeve device 400 for delivery and deployment. FIG. 86A shows agastrointestinal sleeve device 400 in a straight configuration. Thisconfiguration is the simplest for construction and loading of thegastrointestinal sleeve device 400, however it poses some challenges fordelivery and deployment within the patient's gastrointestinal system.The straight gastrointestinal sleeve device 400 would have to beinserted full-length into the patient's small intestines, which would bechallenging because of the torturous path of the small intestines.Another strategy is to invert the gastrointestinal sleeve device 400 sothat it would only have to be directly inserted past the patient'spylorus, with peristaltic action assisting the deployment of the devicewithin the patient's small intestines by eversion of the invertedsections. FIG. 86B shows a gastrointestinal sleeve device 400 loaded ina fully inverted configuration. FIG. 86C shows a gastrointestinal sleevedevice 400 loaded in a double-inverted configuration. This simplifiesthe delivery and deployment of the device, but it adds some additionalconstraints to the configuration of the device. The inverting segmentscan have very thin walls and inverting interfaces can be highlylubricious for easy and reliable deployment. For example blow molded 90A durometer polyurethane of a wall thickness on the order of 0.005″ orless, most preferably about 0.002″, with a lubricious coating will workin this manner. The double inverted configuration has the advantage ofhaving the option to use a distal balloon, or other structure asdescribed earlier, to assist the peristalsis working on its distal endto evert the sleeve. This may avoid the need to use internal pressure toaccomplish the eversion.

The gastrointestinal sleeve device 400 in FIGS. 86B and 86C could beoptionally everted using the method of internal pressurization that iswell known in the everting catheter art. To maintain the internal fluidpressure used to assist in everting the inverted gastrointestinal sleevedevice 400, the distal end of the device may be temporarily sealedduring deployment. FIGS. 87A-87D illustrate four options for sealing thedistal end of a gastrointestinal sleeve device during delivery anddeployment. FIG. 87A shows the inverted distal end of thegastrointestinal sleeve device 400 sealed with a biodegradable tie 900that is formulated to dissolve within approximately 24 hours in theintestines. Dissolution of the biodegradable tie 900 can be aided by asolvent or active agent that is ingested or placed in the optionaleverting fluid. FIG. 87B shows the noninverted distal end of thegastrointestinal sleeve device 400 sealed with a biodegradable tie 900that is formulated to dissolve within approximately 24 hours in theintestines. FIG. 87C shows an inflatable balloon 902 that extends pastthe distal end of the gastrointestinal sleeve device 400. Thegastrointestinal sleeve device 400 can be attached and/or sealed with abiodegradable tie 900 proximal to the balloon 902. The balloon 902 iscarried along through the intestine by peristalsis to deploy thegastrointestinal sleeve device 400 by eversion of the inverted section.When the biodegradable tie 900 dissolves, the balloon 902 detaches anddeflates and is carried harmlessly out through the intestines. Theinflatable balloon 902 may also be made of a biodegradable material.FIG. 87D shows a balloon catheter 904 with an inflatable balloon 906that is inflated within the gastrointestinal sleeve device 400 to form aseal. Once the gastrointestinal sleeve device 400 is fully deployed, theballoon 906 is deflated and the balloon catheter 904 is withdrawn.Please note that the aforementioned 24 hour dissolution time is anexample and, depending on the clinical situation, this time period couldrange from a few hours to many weeks.

FIGS. 88A-88B illustrate a method of delivering and deploying agastrointestinal sleeve device 400. First, an attachment ring device 800or the like is installed in the patient's stomach using any of thedevices and methods previously describe, as shown in FIG. 88A.Subsequently, the pyloric/duodenal introducer 850 with thegastrointestinal sleeve device 400 loaded into it is inserted throughthe patient's pylorus via a peroral route, as shown in FIG. 88B. In thisexample, the proximal portion of the gastrointestinal sleeve device 400is external to the pyloric/duodenal introducer 850 and the distalportion of the sleeve is double inverted inside of the introducer 850similar to the sleeve shown in FIG. 87C. The sleeve ring 810 isinstalled in the attachment ring device 800 and the pyloric/duodenalintroducer 850 is withdrawn. Then, using a combination of fluidpressure, a push rod or catheter 854 inside of the gastrointestinalsleeve device 400 and/or peristalsis of the intestines, optionallyassisted by an inflatable balloon on the catheter or a biodegradablyattached distal peristalsis balloon 902, the gastrointestinal sleevedevice 400 everts to a fully deployed position.

Attachment devices and fasteners are described in FIGS. 49-65, 72-76etc. These attachment devices include means and structures to facilitateattachment using a purely peroral approach. An alternate method foremploying these devices could include assistance via a laparoscopicapproach. This could be indicated in certain clinical situations tofacilitate location of a ring of other structure for attachment as wellas invaginating tissue to form a plication and stabilizing the tissueand ring for attachment. This can be particularly useful in the case ofdouble plications

FIG. 90A illustrates an example of a laparoscopically introduced devicethat works from the outside of the stomach to assist in the formation ofa double plication and the stabilization and attachment of a ring device820. Laparoscope 880 is used to guide one or more laparoscopic tools.One such tool 882 is shown capturing a ring device 820 between a fold oftissue that folds mucosa-to-mucosa rather than serosa-to-serosa.Positioning of fastener delivery device 760 folds the gastric wall toform two serosa-to-serosa plications. A fastener can then follow a paththrough both the plications and the ring 820, which may be configuredsimilar to the ring in FIGS. 81 and 82. FIG. 90B shows the distalstructure of a tool 884 which includes an upper bifurcated fork 886 andlower bifurcated fork 888. The two forks can move relative to each otherto capture tissue and/or apparatus while the use of a bifurcated forkallows their withdrawal after placement of one or more fasteners.

FIG. 95 illustrates a method for placing some configurations ofattachment ring 820, such as the one illustrated in FIG. 81, usinglaparoscopic and standard stapling techniques. In this embodiment andmethod the device 820 is captured within a single plication that isformed by folding the stomach wall over the device so that mucosa is incontact with the attachment area 821 of the device. This attachmentportion 821 of the device can optionally be porous or have open area toallow mucosa to mucosa contact. This area could be made from a PTFEgraft material, a polyester (Marlex) mesh or other material with naturalor formed openings if tissue contact is desired. In this method alaparoscope, external to the stomach, can be used to guide attachment ofthe device through the gastric wall. Standard laparoscopic staplingdevices 890 can be used for this application, as can sutures or otherattachment means. Buttressing of the attachment as described herein maybe indicated in some clinical situations.

The following outline gives a more detailed description of one exampleof a method for delivering and deploying an embodiment of agastrointestinal sleeve device. This procedure assumes a specific deviceconfiguration. Many other device configurations are possible andtherefore some aspects of this procedure may have to be modified toaccommodate other configurations. Device details are as follows:

-   -   1 Ring        -   a Initially parachuted into place on stay sutures        -   b Definitively attached with rivets and riveter, rivet            position is not preset by holes    -   2 Sleeve (mating rings with or without magnet)        -   a Lock sleeve into place        -   b Leak shield attached to sleeve with self-expanding ring        -   c A distal delivery balloon that deflates/detaches/dissolves            in 2-5 days    -   3 Sleeve delivery using        -   a Gastroscopic placement of a guide wire in the duodenum        -   b An over the guidewire sleeve and duodenal introducer        -   c Everting mid-sleeve deployment as it extends distally        -   d A RO distal balloon to advance the distal sleeve by            peristalsis    -   4 Sleeve removal using        -   a A “swallowable” retrieval balloon catheter        -   b Balloon advances to the distal sleeve by swallowing water            for propulsion        -   c Balloon is inflated to wedge against the walls of the            sleeve        -   d Balloon catheter is withdrawn as the proximal sleeve is            withdrawn    -   5 Sleeve replacement by repeating 3    -   6 Ring removal by        -   a Unravelling rivet heads        -   b Retrieving the ring with a gastroscope and grasper

Peroral Gastric Bypass Procedure:

-   -   1 Patient sees physician for referral or self-refers to an        interventionist        -   a. Open surgeon (present)        -   b. Laparoscopic surgeon (present)        -   c. Endoscopist (future)    -   2 Patient is referred to Surgeon/Endoscopist    -   3 Work up is done by support staff    -   4 Patient must qualify        -   a. Psychologically            -   i. Relaxed requirements (compared to current gastric                surgery procedures)        -   b. Medically            -   i. Relaxed requirements (compared to current gastric                surgery procedures)                -   1. Marginal BMI's (e.g. <35)                -   2. Super obese        -   c. Financially (for reimbursement or self-pay)            -   i. Should cost less that surgery    -   5 Patient is seen by Doc performing procedure    -   6 Pre-op counseling    -   7 Pre-op regime for weight loss prior to surgery        -   a. Nothing, not needed for peroral procedure    -   8 Implant sleeve mounting ring        -   a. Check vitals etc.        -   b. Sedation        -   c. IV        -   d. Anesthesia            -   i. May be required for ring attachment            -   ii. Should not be required for most patients for sleeve                procedures        -   e. Prep.        -   f. Place esophageal tube        -   g. Place endoscope in stomach        -   h. Place stay suture            -   i. Identify locations by anatomical land marks            -   ii. Pass suturing device through scope or tube            -   iii. Take bite(s) at location 1, bring suture ends out                of mouth            -   iv. Repeat h (ii & iii) for locations 2, 3 & 4        -   i. Position ring            -   i. Attach stay sutures to ring            -   ii. Fold ring for passage through sleeve            -   iii. Pass ring through sleeve under direct vision using                gastroscope            -   iv. Secure stay sutures to position ring along gastric                wall by GEJ                -   1. Ring design will facilitate forming plications in                    the gastric wall                -   2. Ring design will place gastric wall in position                    for riveting                -   3. Stay sutures can be tied and trimmed in place        -   j. Attach ring            -   i. Pass riveting device through or along scope through                tube                -   1. Scope to include channel for grasper or other                    device                -   2. Position riveter for attaching rivet                -   3. If necessary use grasper to position gastric wall                    at rivet site                -   4. Fire riveter                -   5. Repeat j (i)2-4 as required        -   k. Leak test            -   i. Place mock sleeve in ring (to seal ring opening)            -   ii. Pressurize to leak test            -   iii. Remove mock sleeve        -   l. Remove scope & instruments        -   m. Remove tube    -   9 Wait approximately one month for the ring attachment to heal    -   10 Hang sleeve        -   a. Check vitals etc.        -   b. Sedation (no anesthesia)        -   c. IV        -   d. Prep. Place esophageal tube        -   e. Insert gastroscope to check ring        -   f. Advance gastroscope to duodenum            -   i. Place guidewire in duodenum            -   ii. Remove and replace scope (alongside the guidewire)        -   g. Insert sleeve (sleeve comes pre-positioned on duodenal            introducer)            -   i. Inflate distal balloon            -   ii. Thread system over guidewire            -   iii. Advance through esophageal tube            -   iv. Advance to system to duodenum under direct vision            -   v. Pull back gastroscope proximal to ring            -   vi. Advance system into duodenum (˜2-5 cm) to seat                sleeve in ring                -   1. Manipulate sleeve to mate with ring using grasper                    as required            -   vii. Advance distal and mid sleeves to jejunum (I)                -   1. Pressurize duodenal introducer                -   2. Mid-sleeve everts under pressure (maybe 20-40 cm)                -   3. Advancement of mid-sleeve advances distal sleeve                -   4. Remove duodenal introducer and guidewire                -   5. Allow peristalsis to advance distal sleeve                    balloon OR            -   v. Advance distal and mid sleeves to jejunum (II)                -   1. Use pusher to advance distal sleeve under fluoro                    (balloon acts as bumper)                -   2. Remove duodenal introducer, guidewire & pusher                -   3. Allow peristalsis to advance distal sleeve        -   h. Deploy leak shield            -   i. Manipulate leak shield out of sleeve using grasper as                required            -   ii. Uniformly position leak shield using grasper as                required        -   i. Leak test            -   i. Place balloon catheter in proximal sleeve            -   ii. Inflate balloon to seal sleeve opening            -   iii. Pressurize to leak test            -   iv. Deflate and remove balloon catheter        -   j. Remove scope & instruments        -   k. Wait 2-4 days            -   i. Balloon dissolves/detaches/deflates        -   l. Wait approximately 2 weeks and observe for complication            -   i. Adjust stoma by one of the methods described herein                (if the device is configured to include an adjustable                restrictive stoma)    -   11 Remove sleeve (e.g. to be performed after a therapeutic        period)        -   a. Check vitals etc.        -   b. Sedation (no anesthesia)        -   c. IV        -   d. Swallow removable balloon catheter        -   e. Drink copious amounts of water        -   f. Check balloon position fluoroscopically        -   g. Position gastroscope (with retrieval tool)        -   h. Grasp sleeve at leak shield ring or mating ring        -   i. Inflate removal balloon        -   j. Pull out scope, sleeve and removal balloon simultaneously    -   13 Replace sleeve        -   a. Repeat 10, 11 and 12 as required    -   14 Remove ring        -   a. Check vitals etc.        -   b. Sedation (anesthesia should not be required)        -   c. IV        -   d. Prep.        -   e. Place esophageal tube        -   f. Place endoscope in stomach        -   g. Pass rivet removal tool through tube        -   h. Locate rivets and remove heads        -   i. Using grasper pull ring away from gastric wall        -   j. Pull ring into tube (it should fold as it enters the            tube)        -   k. Visually examine stomach at site of ring        -   l. Remove scope, instruments and tube

In an alternate embodiment, all or part of the sleeve device could beconstructed from a biodegradable polymer as described herein. This wouldobviate the need for removal of the sleeve device at the end of thetreatment period. Material selection and/or selective coatings of theexterior of the biodegradable sleeve could control the rate ofdissolution/degradation of the sleeve in the presence of the differingchemical environments found at different locations along the alimentarytract. For example a Parylene coating in the sleeve in the stomach,pylorus and duodenum could inhibit the effects of the stomach acids.This would be less of an issue after these acids mix with the basicsecretions of bile in the duodenum an beyond in the jejunum.

Morbid obesity endoscopic transgastric diaphragmatic attachment, a.k.a.Gastropexy attachment, and apparatus are described for attaching devicesand/or securing tissue at or near the gastroesophageal junction andcardia of the stomach. The method and apparatus allow attachment toinclude securing the tissue and/or device to the diaphragm and/orconnecting the diaphragm to the esophagus via a peroral endoscopicapproach. Attaching tissue to the diaphragm is common in Nissenfundoplication surgery using conventional methods.

A fastener or other attachment structure can be passed through thegastric wall and through the diaphragm while manipulating surroundingtissue, including the esophagus and the lungs, to avoid damage to thesetissues.

FIG. 92 illustrates a gastropexy apparatus 910. The apparatus caninclude an endoscope 911 with a distraction means 912, transilluminationmeans 913, and securing means 914 slidably mounted on the endoscope witha control tail 915 to control the position of these components along theendoscope 911. A fastener delivery/deployment device 916 is insertablethrough working channel of endoscope 911. The transillumination means913 may be an LED or optical fiber. The optical fiber can be plastic orglass. The wavelength of light used for transillumination can be avisible wavelength selected for penetration of tissue.

The embodiment of FIG. 92 shows a balloon as the distraction means 912,suction as the securing means 914 and an LED as the transilluminationmeans 913 for aiming the fastener delivery/deployment device 916. Thecombination of distraction and securing the esophageal wall creates apocket into which a fastener 918 can be safely deployed.Transillumination through the tissue structures, i.e. the esophagealwall, diaphragm and gastric wall, is a preferred, though not required,method to aim the fastener delivery/deployment device 916. Alternativelyof in addition, an ultrasound imaging or location device can be mountedon the device or externally.

A standard flexible endoscope may be used with the distraction means,securing means and optional transillumination means being incorporatedinto a device that can be removably attached to the endoscope.Alternatively, these features can be incorporated into a combinedendoscope device.

Various types of fasteners, including those described elsewhere in thisspecification, can be used in this method. T-type or otherexpanding-head or deployable fasteners are preferable. Fasteners caninclude features that allow: 1) placement of the fastener, 2) removal ofthe delivery/deployment device, 3) positioning or actuation of afastener attachment means, and 4) if necessary, removal of excessmaterial from the fastener.

After delivery/deployment of the distal T of the fastener 918 in thesafe zone above the diaphragm, the delivery/deployment device 916 canthen be removed. An attachment means can be advanced into position overthe proximal tail of the fastener 918, which extends through theendoscope 911. The fastener attachment means can screw, crimp, snap orotherwise attach to the attachment zone of the fastener. An additionaldevice may or may not be required for delivering and attaching thefastener attachment means, depending on the attachment mechanismutilized. Excess material, including the proximal tail, can then be cutotherwise detached and removed.

The method of use could involve the steps of: 1) advancing the distaltip of the endoscope into contact with the gastric wall, 2) continuingto advance the endoscope until the gastric wall contacts the diaphragm,3) manipulating the endoscope to visualize the transillumination means,and 4) actuating the fastener. The method may also involve the use ofstay sutures to preposition a device for attachment. These stay suturescould be used optionally to parachute the device into position throughthe esophagus.

One possible method for gastropexy attachment would be performed asfollows:

-   -   1. Position endoscope overtube    -   2. Attach gastropexy protector (GP) to exterior of endoscopy and        attach required accessories (suction, light source, inflation        syringe). Calibrate delivery device advancement stop.    -   3. Insert endoscope (1-channel) with mounted GP    -   4. Turn on transillumination (TI) light to transmit light        through an optical fiber, or bundle.    -   5. Position scope so GP is positioned just above the diaphragm.        Position scope for T-tag gastropexy. View TI light to assist in        positioning.    -   6. Apply suction to esophagus    -   7. Inflate GP protection balloon    -   8. Confirm scope position with TI light and advance T-tag        deployment device with its integrated tissue protector to the        gastric wall. Continue advancing device until exterior of the        gastric wall contacts the diaphragm    -   9. Reconfirm scope position with TI light, retract tissue        protector, pass T-tag delivery cannula through the diaphragm        until the advancing stop is reached and using T-tag device,        deploy T-tag in safe zone above diaphragm    -   10. Retract T-tag deployment device out through diaphragm    -   11. Release vacuum    -   12. Deflate balloon    -   13. Remove scope and position tails externally    -   a. Repeat steps 5-13 6 times    -   14. Pre-thread T-tag tails sleeve ring    -   15. Prepare to parachute sleeve ring through over tube and pass        sleeve ring through overtube.    -   16. Snug T-tag tails to position device(s) and ready for final        attachment    -   17. Using tails, guide the T-tag securement caps (crimp, snap or        screw) into position and secure in place (Repeat 6 times)    -   18. Trim tails and remove all instrumentation

Optionally, the gastropexy apparatus may also include a delivery devicetip protector. The delivery device tip protector can be a removableobturator that is coaxial with an exemplary hollow needle introducer.The obdurator is removed after the delivery cannula is in place andreplaced with a T-tag deployment mechanism and its associated T-tag(s)

Additionally, the gastropexy apparatus may include a delivery deviceadvancement stop. The stop can be a structure that can be adjustablyfixed to a position on the proximal portion of the T-tag delivery devicethat is connected to and thereby controls the position of the degree towhich the T-tag delivery cannula extends from the distal end of theendoscope. This could be a collar with a thumbscrew lock

Description of the calibration of the advancement stop procedure—Attachthe GP to the endoscope; bend the endoscope so that the distal tip ofthe scope aligns with the transillumination light; extend the T-tagdelivery cannula until it is a set distance from the transilluminationlight (on the order of 0.25″ or 6 mm); position advancement stop againstthe working channel proximal port; then secure advancement stop. Confirmcalibration of advancement stop by straightening and re-bending thescope then adjusting the position of the stop if necessary.

While the present invention has been described herein with respect tothe exemplary embodiments and the best mode for practicing theinvention, it will be apparent to one of ordinary skill in the art thatmany modifications, improvements and subcombinations of the variousembodiments, adaptations and variations can be made to the inventionwithout departing from the spirit and scope thereof.

1.-20. (canceled)
 21. A method of treating a patient, comprising:providing a sleeve, having a proximal end, a distal end, and a lumenextending therethrough; providing a tubular cuff having a proximal endand a distal end, the distal end of the cuff attached to the proximalend of the sleeve; transesophageally advancing the cuff to position theproximal end of the cuff adjacent an attachment site of a luminal wallin the lower esophagus; attaching the tubular cuff at the attachmentsite without creating a serosal to serosal bond, such that the sleeve isconfigured to deliver food from the lower esophagus into the stomach;wherein the attaching the tubular cuff comprises anchoring at least onetissue anchor having a proximal end and a distal end, said anchoringcomprising changing the distal end of the tissue anchor from atransversely reduced configuration used while passing through themuscularis layer of the attachment site to a transversely enlargedconfiguration used after passing through the attachment site, whereinthe distal end of the tissue anchor includes a proximally facing surfacewhich rests against a distally facing surface to retain the tubularcuff, and wherein the enlarged configuration of the tissue anchor istransversely larger than any transverse portion of the tissue anchorwhen the tissue anchor is passing through the attachment site.
 22. Amethod of treating a patient as in claim 21, wherein the tissue anchorcomprises a “T” tag.
 23. A method of treating a patient as in claim 21,wherein the transversely enlarged configuration is achieved by expandingthe anchor after passing through the muscularis tissue.
 24. A method oftreating a patient as in claim 21, wherein the transversely enlargedconfiguration is achieved by flexing a portion of the anchor afterpassing through the muscularis tissue.
 25. A method of treating apatient as in claim 21, wherein the cuff and the sleeve do not comprisea valve.
 26. A method of treating a patient as in claim 21, wherein thesleeve is porous.
 27. A method of treating a patient as in claim 21,wherein the sleeve is nonporous.
 28. A method of treating a patient asin claim 21, further comprising positioning the distal end of the sleeveproximate a pylorus of the stomach.
 29. A method of treating a patientas in claim 21, further comprising positioning the distal end of thesleeve in an antrum of the stomach.
 30. A method of treating a patientas in claim 21, further comprising positioning the distal end of thesleeve in a fundus of the stomach.